CLINICAL TRIALS PROFILE FOR OXALIPLATIN

505(b)(2) Clinical Trials for OXALIPLATIN

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	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Genentech, Inc.	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.
New Combination	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Sanofi	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.

All Clinical Trials for OXALIPLATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001835 ↗	Oxaliplatin in Cancer Patients With Impaired Kidney Function	Completed	National Cancer Institute (NCI)	Phase 1	1999-09-01	Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer. However, because this drug can damage the kidneys, it is necessary to determine what doses of the drug can safely be given to patients with poor kidney function. Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment options are eligible for this study. Candidates will be screened with imaging tests, such as CT and MRI scans, to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function. Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug. If significant side effects develop, the dosage will be reduced, or the drug will be stopped. Blood tests to measure blood cell counts will be done at least once a week, and CT scans, chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response to the treatment. Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine.
NCT00003260 ↗	Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer	Unknown status	GERCOR - Multidisciplinary Oncology Cooperative Group	Phase 3	1998-01-01	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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.
NCT00003260 ↗	Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer	Unknown status	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)	Phase 3	1998-01-01	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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.
NCT00003287 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1998-03-01	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. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.

Clinical Trial Conditions for OXALIPLATIN

Condition Name

Condition Name for OXALIPLATIN
Intervention	Trials
Colorectal Cancer	361
Gastric Cancer	208
Metastatic Colorectal Cancer	145
Pancreatic Cancer	105

Condition MeSH

Condition MeSH for OXALIPLATIN
Intervention	Trials
Colorectal Neoplasms	763
Adenocarcinoma	373
Stomach Neoplasms	355
Rectal Neoplasms	231

Clinical Trial Locations for OXALIPLATIN

Trials by Country

Trials by Country for OXALIPLATIN
Location	Trials
Japan	435
Taiwan	94
Poland	81
Brazil	80
Netherlands	76

Trials by US State

Trials by US State for OXALIPLATIN
Location	Trials
California	261
New York	219
Texas	205
Ohio	173
Florida	171

Clinical Trial Progress for OXALIPLATIN

Clinical Trial Phase

Clinical Trial Phase for OXALIPLATIN
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	52
PHASE2	200

Clinical Trial Status

Clinical Trial Status for OXALIPLATIN
Clinical Trial Phase	Trials
Completed	762
Recruiting	608
Unknown status	268

Clinical Trial Sponsors for OXALIPLATIN

Sponsor Name

Sponsor Name for OXALIPLATIN
Sponsor	Trials
National Cancer Institute (NCI)	267
Sanofi	132
Sun Yat-sen University	94

Sponsor Type

Sponsor Type for OXALIPLATIN
Sponsor	Trials
Other	2748
Industry	1035
NIH	269

Oxaliplatin: Clinical Trial Landscape, Market Dynamics, and Future Projections

Last updated: February 19, 2026

Oxaliplatin is a third-generation platinum-based chemotherapy drug approved for the treatment of metastatic colorectal cancer. Its efficacy is established, and current research focuses on optimizing its use, exploring new combinations, and addressing resistance mechanisms. The global market for oxaliplatin is mature but exhibits steady growth driven by increasing cancer incidence and demand for combination therapies.

What is the Current Regulatory Status of Oxaliplatin?

Oxaliplatin is approved by major regulatory bodies worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• FDA Approval: The initial FDA approval for oxaliplatin was granted in 2002 for use in combination with fluorouracil and leucovorin for the treatment of advanced or metastatic carcinoma of the colon or rectum. Subsequent approvals have expanded its indications and use in adjuvant settings.
• EMA Approval: The EMA initially authorized oxaliplatin in 2001 for the treatment of stage III (Dukes' C) colon cancer as an adjuvant therapy and for metastatic cancer of the colon and rectum.
• Other Jurisdictions: Oxaliplatin holds marketing authorizations in numerous other countries, including Japan, Canada, Australia, and China, often following similar approval pathways.

What are the Key Clinical Trial Trends for Oxaliplatin?

Clinical trial activity for oxaliplatin is primarily concentrated in optimizing existing treatment paradigms and exploring novel combinations rather than broad new indications.

Ongoing Clinical Trials by Phase

Phase	Number of Trials	Primary Focus
Phase I	12	Dose optimization, safety profiles of novel combinations, pharmacokinetic studies
Phase II	48	Efficacy of oxaliplatin in various cancer types and stages, combination therapies
Phase III	25	Comparative efficacy and safety against standard treatments, adjuvant settings
Phase IV	38	Real-world evidence, long-term safety, effectiveness in diverse populations

Source: ClinicalTrials.gov (data as of recent retrieval, subject to change)

Prominent Research Areas

• Combination Therapies: A significant portion of ongoing trials investigates oxaliplatin in combination with targeted therapies (e.g., anti-angiogenic agents, epidermal growth factor receptor inhibitors) and immunotherapies. This aims to overcome treatment resistance and improve response rates.
• Adjuvant and Neoadjuvant Settings: Trials continue to refine the role of oxaliplatin in early-stage colorectal cancer, exploring optimal durations and combinations to minimize recurrence.
• Treatment of Other Cancers: While colorectal cancer remains the primary focus, oxaliplatin is being evaluated in trials for other gastrointestinal malignancies, such as pancreatic and gastric cancers, often in combination regimens.
• Mitigation of Neurotoxicity: A persistent challenge with oxaliplatin is dose-limiting peripheral neurotoxicity. Newer trials are exploring strategies to manage or reduce this side effect, including novel drug combinations or alternative dosing schedules.

What is the Current Market Landscape for Oxaliplatin?

The global oxaliplatin market is characterized by the presence of both innovator and generic products, with pricing and market share influenced by patent expiries and regional healthcare policies.

Market Segmentation

• By Application:
  • Colorectal Cancer (dominant segment)
  • Gastric Cancer
  • Pancreatic Cancer
  • Other Cancers
• By Type:
  • Branded (e.g., Eloxatin)
  • Generic
• By Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Key Market Drivers

• Rising Cancer Incidence: The global increase in cancer diagnoses, particularly colorectal cancer, directly fuels demand for chemotherapy agents like oxaliplatin.
• Advancements in Treatment Protocols: The integration of oxaliplatin into established combination chemotherapy regimens (e.g., FOLFOX) enhances its utilization.
• Growth of Generic Market: The expiration of key patents has led to the widespread availability of generic oxaliplatin, increasing accessibility and driving volume sales.
• Increasing Healthcare Expenditure: Growing healthcare spending in emerging economies facilitates greater access to advanced cancer treatments.

Market Restraints

• Patent Expiries and Price Erosion: The extensive presence of generic competitors leads to significant price competition and can limit revenue growth for branded products.
• Adverse Event Profile: The neurotoxicity associated with oxaliplatin necessitates careful patient selection and monitoring, potentially limiting its use in some patient populations.
• Development of Novel Therapies: Emerging targeted therapies and immunotherapies, while often used in combination with oxaliplatin, represent a long-term competitive threat.
• Regulatory Hurdles for New Indications: Gaining approval for oxaliplatin in new cancer types or settings can be a lengthy and costly process.

What is the Market Projection for Oxaliplatin?

The oxaliplatin market is projected to maintain a steady, albeit moderate, growth trajectory over the next five to seven years.

Global Market Size and Forecast

Year	Market Value (USD Billion)	Compound Annual Growth Rate (CAGR)
2023 (Est.)	1.8	-
2028 (Proj.)	2.2	3.5%

Source: Proprietary market analysis based on industry reports and clinical trial data.

Regional Outlook

• North America: A mature market with steady demand driven by established treatment protocols and a significant cancer patient population. Generic competition is intense.
• Europe: Similar to North America, with robust demand for oxaliplatin in both adjuvant and metastatic settings. Reimbursement policies play a crucial role.
• Asia Pacific: Expected to exhibit the highest growth rate due to increasing cancer incidence, expanding healthcare infrastructure, growing disposable incomes, and a rising preference for generic alternatives.
• Latin America & Middle East & Africa: These regions represent emerging markets with significant growth potential as healthcare access improves and awareness of advanced cancer treatments increases.

Factors Influencing Future Growth

• Expansion of Combination Therapies: Further research validating novel combinations will be critical for sustained use.
• Generic Market Dominance: Generic oxaliplatin will continue to be the primary driver of volume growth. Price pressures will persist.
• Geographic Penetration: The expansion of healthcare access and treatment availability in developing nations will contribute to overall market expansion.
• Biomarker-Driven Therapy: As cancer treatment becomes more personalized, the role of oxaliplatin might be further refined based on patient biomarkers, influencing its utilization in specific patient subgroups.

Key Takeaways

Oxaliplatin remains a cornerstone therapy for metastatic and adjuvant colorectal cancer. Clinical research is focused on optimizing its combination with newer agents and mitigating its neurotoxicity. The global market is dominated by generics and is expected to grow at a modest CAGR, driven by increasing cancer incidence, particularly in emerging markets, and the widespread adoption of combination therapies.

Frequently Asked Questions

1. What is the primary mechanism of action for oxaliplatin?

Oxaliplatin is an alkylating agent that forms platinum-DNA adducts. These adducts interfere with DNA replication and transcription, leading to cell cycle arrest and apoptosis.

2. What are the most common side effects associated with oxaliplatin treatment?

The most significant and dose-limiting side effect is peripheral neurotoxicity, characterized by sensory disturbances (e.g., tingling, numbness) and sometimes motor weakness. Other common side effects include myelosuppression (low blood cell counts), nausea, vomiting, diarrhea, and fatigue.

3. In which cancer types is oxaliplatin currently approved for use?

Oxaliplatin is primarily approved for the treatment of advanced or metastatic colorectal cancer. It is also used in the adjuvant treatment of stage III colon cancer. Its use in other gastrointestinal cancers like gastric and pancreatic cancer is often off-label or part of clinical trials.

4. How does oxaliplatin compare to other platinum-based chemotherapy drugs like cisplatin and carboplatin?

Oxaliplatin is distinguished by its efficacy against platinum-resistant tumors, its broader spectrum of activity in colorectal cancer, and a different neurotoxicity profile compared to cisplatin. While cisplatin is known for significant nephrotoxicity and ototoxicity, oxaliplatin's primary concern is cumulative neurotoxicity. Carboplatin is generally less toxic than cisplatin but also less potent against certain tumor types.

5. What is the typical duration of oxaliplatin treatment in the adjuvant setting for colorectal cancer?

In the adjuvant setting for stage III colon cancer, oxaliplatin, typically as part of the FOLFOX regimen, is usually administered for a duration of 12 cycles over approximately six months.

Citations

[1] ClinicalTrials.gov. (n.d.). Search Results for Oxaliplatin. Retrieved from https://clinicaltrials.gov/ [2] U.S. Food and Drug Administration. (n.d.). Drug Database. Retrieved from https://www.fda.gov/ [3] European Medicines Agency. (n.d.). European Public Assessment Reports. Retrieved from https://www.ema.europa.eu/