CLINICAL TRIALS PROFILE FOR XELODA

505(b)(2) Clinical Trials for XELODA

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	Roche Pharma AG	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Sanofi	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Cancer Research Network	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	Rutgers Cancer Institute of New Jersey	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	Rutgers, The State University of New Jersey	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.

All Clinical Trials for XELODA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003704 ↗	Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
NCT00003704 ↗	Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 1	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
NCT00004183 ↗	Capecitabine in Treating Patients With Malignant Mesothelioma	Completed	National Cancer Institute (NCI)	Phase 2	2000-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have malignant mesothelioma.
NCT00004183 ↗	Capecitabine in Treating Patients With Malignant Mesothelioma	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2000-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have malignant mesothelioma.
NCT00006108 ↗	Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1999-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
NCT00006108 ↗	Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer	Completed	UNC Lineberger Comprehensive Cancer Center	Phase 1/Phase 2	1999-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
NCT00008034 ↗	Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 1	2000-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and shrink tumors so they can be removed during surgery. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.

Clinical Trial Conditions for XELODA

Condition Name

Condition Name for XELODA
Intervention	Trials
Breast Cancer	103
Colorectal Cancer	65
Gastric Cancer	43
Pancreatic Cancer	36

Condition MeSH

Condition MeSH for XELODA
Intervention	Trials
Breast Neoplasms	175
Colorectal Neoplasms	128
Rectal Neoplasms	83
Stomach Neoplasms	74

Clinical Trial Locations for XELODA

Trials by Country

Trials by Country for XELODA
Location	Trials
Spain	138
China	132
Canada	107
Italy	82
Brazil	64

Trials by US State

Trials by US State for XELODA
Location	Trials
Texas	91
California	88
New York	72
Florida	70
Pennsylvania	59

Clinical Trial Progress for XELODA

Clinical Trial Phase

Clinical Trial Phase for XELODA
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for XELODA
Clinical Trial Phase	Trials
Completed	288
Terminated	90
Recruiting	87

Clinical Trial Sponsors for XELODA

Sponsor Name

Sponsor Name for XELODA
Sponsor	Trials
Hoffmann-La Roche	96
National Cancer Institute (NCI)	93
M.D. Anderson Cancer Center	29

Sponsor Type

Sponsor Type for XELODA
Sponsor	Trials
Other	687
Industry	347
NIH	94

Xeloda (capecitabine): Clinical-Stage Updates, Market Read, and Forward Projections

Last updated: May 3, 2026

What is Xeloda and what is the current clinical footprint?

Xeloda is capecitabine, an oral prodrug of 5-fluorouracil (5-FU). It is approved and used across major solid-tumor settings where fluoropyrimidines form backbone regimens, including metastatic colorectal cancer and metastatic breast cancer (in combination with taxanes or platinum-based therapy depending on line and locale), as reflected in global prescribing information. Capecitabine is also used as adjuvant therapy in colorectal cancer after curative resection in multiple jurisdictions.

Clinical-trial activity for capecitabine is dominated by:

• Comparative studies in standard-of-care regimens (chemo combinations, dose or schedule refinements, and biomarker stratification)
• Trials in earlier lines and adjuvant settings
• Studies in rare combinations (targeted therapy plus fluoropyrimidine backbones)

Key structural point for market-linked trial reading: because capecitabine is long-established, most trial incremental value comes from evidence that changes positioning (new combinations, line of therapy, or label expansions). For an investor or R&D owner, the decision-relevant question is whether new data is strong enough to shift practice away from 5-FU/leucovorin IV or toward capecitabine-based oral regimens, and whether outcomes justify payer and guideline shifts.

What trials and data streams move the market the most?

Market impact from capecitabine trials typically flows through three channels:

1) Line-of-therapy displacement

Trials that show non-inferiority or superiority versus IV 5-FU-based regimens can shift physicians toward oral convenience with similar efficacy and acceptable safety.

2) Combination regimen adoption

Capecitabine’s market performance tends to track adoption of specific backbone regimens in oncology. Evidence supporting tolerability and continuity of dosing in combination therapy is a high-leverage factor for real-world uptake.

3) Adjuvant and localized disease reinforcement

Adjuvant data that supports capecitabine as a standard option expands the addressable population and stabilizes demand outside metastatic cycles.

Practical update framing (what to watch in ongoing capecitabine trials):

• Trials that report clinically meaningful improvements in progression-free survival, overall survival, or durable response rates in clinically relevant subgroups
• Studies that improve dose intensity or reduce grade 3/4 hand-foot syndrome and diarrhea while maintaining efficacy

How does the competitive landscape affect Xeloda demand?

Xeloda’s main competitive pressures are:

• Alternative fluoropyrimidine options: IV 5-FU/leucovorin, and other oral fluoropyrimidine strategies where available
• Broad oncology regimen competition: targeted therapies, antibody-drug conjugates, and immunotherapy shifting the sequencing of chemotherapy backbones
• Biosimilar and generics: capecitabine is widely off-patent in most markets, with branded demand facing price and channel competition

That last point shapes the market outlook more than any single clinical endpoint. Even if new trials support usage, generic penetration constrains pricing power.

What is the market model for capecitabine branded revenue?

For Xeloda-branded performance, the market is shaped by:

• Remaining exclusivity windows by territory (brand protection versus generic erosion)
• Payer formularies and procurement preference for lowest-cost alternatives
• Conversion economics: oral chemo uptake depends on patient suitability and physician habit, but payer cost dominates long-run brand share once generics saturate

Implication: branded growth is unlikely to be driven by new efficacy alone once generics are entrenched. The binding constraints are share of prescriptions and ASP (average selling price) compression.

What is the current market analysis for Xeloda and capecitabine?

Xeloda sits in one of the largest solid-tumor chemo segments globally because colorectal and breast cancers are high-incidence indications and fluoropyrimidines are embedded in standard practice.

Demand drivers

• Broad use of fluoropyrimidine-based chemotherapy
• Long disease duration and repeated lines in metastatic colorectal settings
• Adjuvant use in resected colorectal cancer keeps consumption steady beyond metastatic dynamics

Demand inhibitors

• Generics and channel competition
• Changes in chemotherapy sequencing due to targeted and immuno-oncology regimens
• Safety and adherence constraints for oral dosing (hand-foot syndrome and GI toxicity), which can drive switching back to IV in some patient cohorts

Where does growth come from in the projection period?

Growth in capecitabine consumption can come from:

1. Volume growth: rising incidence of colorectal and breast cancers and expanded treatment penetration
2. Regimen stickiness: continued guideline inclusion of fluoropyrimidines
3. New combination uptake: evidence that supports capecitabine backbones in lines and subgroups

But branded Xeloda revenue growth depends on whether price declines slow and whether market share stabilizes versus generics.

Forward projection: base-case demand and branded revenue trajectory

A practical projection framework for Xeloda branded revenue is a product-of-three model:

• Prescriptions in eligible indications (volume)
• Share that remains branded (share vs generics and distribution contracting)
• Net price (ASP after rebates and tenders)

Base case (typical off-patent branded behavior for established oncology chemo):

• Volume grows modestly with oncology incidence and treatment penetration
• Branded share trends downward or flattens depending on procurement mechanics
• Net price continues to compress, with the decline rate slowing once the most aggressive tender cycles mature

Bull case (less common):

• Label expansions or combination wins create pockets where physicians preferentially select the brand (patient support programs, supply reliability, or dosing guidance)
• Branded share stabilizes because formulary tiering keeps Xeloda usable even when generics exist

Bear case (most typical):

• Further aggressive procurement and competition continue ASP compression
• Sequencing shifts away from chemo backbones in some subgroups reduce capecitabine usage intensity

What are the specific clinical safety and dosing factors that can affect future utilization?

Xeloda utilization hinges on manageable toxicity and patient ability to maintain oral therapy. The product’s known safety profile, including hand-foot syndrome and gastrointestinal adverse reactions, influences:

• Dose modification patterns
• Discontinuation rates
• Physician preference for alternatives in patients with comorbidities or prior intolerance

Any trial that demonstrably improves tolerability without compromising efficacy can raise realized utilization even if headline response rates are similar.

How should investors and R&D leaders interpret trial updates for a mature brand?

For an established drug like capecitabine, the decision-grade information is not “more trials,” it is:

• Evidence that changes sequencing (first-line vs second-line repositioning)
• Evidence that broadens eligibility (biomarker stratification or new subpopulations)
• Evidence that improves dose delivery (tolerability and dose intensity)
• Evidence that changes payer behavior (which is often tied to guideline uptake and cost-effectiveness)

Absent label-impacting results, most incremental trial readouts drive incremental science but do not shift market share meaningfully, especially under generic competition.

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Key Takeaways

• Xeloda (capecitabine) remains a core fluoropyrimidine backbone in colorectal and breast oncology, with continued clinical use across metastatic and adjuvant settings.
• Market outcomes for Xeloda branded revenue are dominated by generic penetration, tender mechanics, and net price compression rather than incremental efficacy gains alone.
• Trial value for a mature, off-patent molecule is highest when data changes line-of-therapy placement, expands eligible populations, or improves tolerability enough to increase dose continuity.
• Forward branded revenue projection follows a base-case path of modest volume growth with continued branded share pressure and ASP compression, with bull-case outcomes requiring label or guideline-impacting combination adoption.

FAQs

1. What is Xeloda’s active ingredient and mechanism?
   Capecitabine, an oral prodrug that converts to 5-fluorouracil in tissues.

2. Which cancers drive Xeloda usage?
   Colorectal cancer (including adjuvant and metastatic settings) and breast cancer (metastatic in combination regimens depending on line and locale).

3. Why do clinical trials matter differently for Xeloda than for a new drug?
   Because Xeloda is mature and off-patent in most markets, clinical evidence must drive guideline or sequencing changes to counter generic and pricing pressures.

4. What safety issues most affect real-world continuation?
   Hand-foot syndrome and gastrointestinal toxicities that trigger dose reductions or discontinuation.

5. What is the main determinant of Xeloda branded revenue over time?
   Net price and branded share versus generics, influenced by procurement and payer formularies.

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References

[1] U.S. Food and Drug Administration. Xeloda (capecitabine) prescribing information. FDA label database.
[2] European Medicines Agency. Xeloda (capecitabine) product information. EMA medicines database.
[3] National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: Colon Cancer; Breast Cancer (fluoropyrimidine-based chemotherapy regimens and sequencing).
[4] PubMed/clinical trial registries (e.g., ClinicalTrials.gov). Capecitabine-related interventional trial records.