CLINICAL TRIALS PROFILE FOR ELOXATIN

505(b)(2) Clinical Trials for Eloxatin

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	NCT01489865 ↗	ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer	Unknown status	Abbott	Phase 1/Phase 2	2011-02-01	People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
New Combination	NCT01489865 ↗	ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer	Unknown status	Georgetown University	Phase 1/Phase 2	2011-02-01	People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
New Combination	NCT01522989 ↗	PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies	Unknown status	Pfizer	Phase 1	2011-12-01	This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.

All Clinical Trials for Eloxatin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003799 ↗	Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-05-01	Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be an effective treatment for rectal cancer
NCT00004102 ↗	Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1999-01-01	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 may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.
NCT00004102 ↗	Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer	Completed	New York University School of Medicine	Phase 2	1999-01-01	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 may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.
NCT00004102 ↗	Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer	Completed	NYU Langone Health	Phase 2	1999-01-01	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 may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.
NCT00004931 ↗	Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2000-02-01	Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer. 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 combination chemotherapy regimen is more effective for colon cancer

Clinical Trial Conditions for Eloxatin

Condition Name

Condition Name for Eloxatin
Intervention	Trials
Colorectal Cancer	36
Gastric Cancer	23
Metastatic Colorectal Cancer	20
Pancreatic Cancer	17

Condition MeSH

Condition MeSH for Eloxatin
Intervention	Trials
Adenocarcinoma	97
Colorectal Neoplasms	93
Stomach Neoplasms	51
Rectal Neoplasms	47

Clinical Trial Locations for Eloxatin

Trials by Country

Trials by Country for Eloxatin
Location	Trials
Canada	52
China	38
United Kingdom	24
Spain	22
Australia	18

Trials by US State

Trials by US State for Eloxatin
Location	Trials
Texas	64
California	61
New York	55
Ohio	43
Florida	40

Clinical Trial Progress for Eloxatin

Clinical Trial Phase

Clinical Trial Phase for Eloxatin
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	41
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Eloxatin
Clinical Trial Phase	Trials
Completed	153
Terminated	55
Recruiting	48

Clinical Trial Sponsors for Eloxatin

Sponsor Name

Sponsor Name for Eloxatin
Sponsor	Trials
National Cancer Institute (NCI)	118
Sanofi	37
M.D. Anderson Cancer Center	28

Sponsor Type

Sponsor Type for Eloxatin
Sponsor	Trials
Other	352
Industry	155
NIH	119

ELOXATIN (Oxaliplatin): Clinical Trials, Market Analysis, and Projections

Introduction to ELOXATIN (Oxaliplatin)

ELOXATIN, also known as oxaliplatin, is a chemotherapy drug used primarily in the treatment of colorectal cancer. It is a platinum-based drug that works by interfering with the DNA of cancer cells, preventing them from reproducing and eventually leading to cell death.

Clinical Trials and Efficacy

Adjuvant Treatment of Colon Cancer

One of the pivotal clinical trials evaluating the efficacy of oxaliplatin is the MOSAIC trial. This international, multicenter, randomized trial involved patients with stage II (Dukes' B2) or III (Dukes' C) colon cancer who had undergone complete resection of the primary tumor. Patients were randomized to receive either oxaliplatin with fluorouracil/leucovorin or fluorouracil/leucovorin alone for a total of 6 months. The results showed that patients who received oxaliplatin with fluorouracil/leucovorin had a significantly longer time to tumor progression and overall survival compared to those who received fluorouracil/leucovorin alone[1].

Advanced Colorectal Cancer

In another significant trial, patients with advanced adenocarcinoma of the colon and rectum were treated with different regimens, including oxaliplatin in combination with fluorouracil/leucovorin. This trial demonstrated that the combination of oxaliplatin with fluorouracil/leucovorin resulted in a longer time to tumor progression, higher confirmed response rates, and improved overall survival compared to other treatment arms, including irinotecan with fluorouracil/leucovorin[1].

Second-Line Treatment

A multicenter, open-label, randomized trial evaluated oxaliplatin as a second-line treatment for patients with metastatic colorectal cancer who had relapsed or progressed during or within 6 months of first-line treatment. The trial showed that the combination of oxaliplatin with fluorouracil/leucovorin was effective in improving outcomes for these patients[1].

Safety and Toxicity

Clinical trials have also highlighted the safety profile of oxaliplatin. Common toxicities include neutropenia, which can be cumulative and more protracted as treatment continues. Other significant grade 3 and 4 toxicities include thrombocytopenia, anemia, and non-hematologic toxicities such as nausea, vomiting, and neuropathy[4].

Market Analysis

Global Market Size and Growth

The global oxaliplatin market was valued at USD 965.94 million in 2023 and is projected to reach USD 2,065.74 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 8.81% during the forecast period from 2024 to 2032. This growth is driven by the increasing prevalence of colorectal cancer worldwide and the demand for effective chemotherapy drugs[2].

Regional Market Share

North America is the largest market shareholder for oxaliplatin, driven by increased awareness of cancer treatment options and a rise in colorectal cancer cases. The region is expected to expand substantially during the forecast period. The Asia-Pacific region is identified as the fastest-growing market, reflecting the increasing incidence of colorectal cancer in this area[2].

Technological Advancements

Technological innovations, such as lyophilization (a freeze-drying technique), have enhanced the stability and shelf life of oxaliplatin, reducing the risk of side effects and making it more suitable for clinical use. These advancements are expected to drive further growth and innovation in the oxaliplatin market[2].

Market Projections

Impact of Cancer Prevalence

The rising incidence of colorectal cancer globally is a key driver for the demand for oxaliplatin. For instance, in the United States, approximately 104,621 new cases of colon cancer and 43,340 cases of rectal cancer were estimated in 2020, with a projected continued high incidence of colorectal cancer[2].

Recovery from COVID-19 Impact

In regions like China, the sales value of oxaliplatin decreased in 2020 due to the COVID-19 pandemic's impact on hospital services. However, the market is expected to experience restorative growth from 2021 to 2025 as the pandemic's effects alleviate. The increasing number of colon cancer cases in China, which rose by 46.28% from 2018 to 2020, will also contribute to the growth in oxaliplatin sales[5].

Future Outlook

The future outlook for the oxaliplatin market is promising, driven by ongoing research, technological advancements, and the increasing demand for effective cancer treatments. As cancer rates continue to rise, the need for drugs like oxaliplatin will remain high, ensuring sustained market growth.

Key Takeaways

• Clinical Efficacy: Oxaliplatin has demonstrated significant efficacy in combination with fluorouracil/leucovorin in treating colon and rectal cancer, improving time to tumor progression and overall survival.
• Market Growth: The global oxaliplatin market is projected to grow from USD 965.94 million in 2023 to USD 2,065.74 million by 2032, with a CAGR of 8.81%.
• Regional Dominance: North America is the largest market for oxaliplatin, with the Asia-Pacific region showing the fastest growth.
• Technological Advancements: Innovations like lyophilization are enhancing the stability and clinical use of oxaliplatin.
• Impact of Cancer Prevalence: Rising colorectal cancer rates globally are driving the demand for oxaliplatin.

FAQs

What is ELOXATIN (oxaliplatin) used for?

ELOXATIN (oxaliplatin) is primarily used in the treatment of colorectal cancer, often in combination with other chemotherapy drugs like fluorouracil and leucovorin.

What are the key clinical trials that have evaluated the efficacy of oxaliplatin?

Key trials include the MOSAIC trial for adjuvant treatment of colon cancer and several trials evaluating oxaliplatin in combination with fluorouracil/leucovorin for advanced colorectal cancer.

What are the common side effects of oxaliplatin?

Common side effects include neutropenia, thrombocytopenia, anemia, nausea, vomiting, and neuropathy.

How is the global oxaliplatin market expected to grow?

The global oxaliplatin market is projected to grow from USD 965.94 million in 2023 to USD 2,065.74 million by 2032, with a CAGR of 8.81%.

Which regions are driving the growth of the oxaliplatin market?

North America is the largest market, while the Asia-Pacific region is the fastest-growing market for oxaliplatin.

Sources

1. Pfizer Medical Information: Oxaliplatin injection Clinical Studies.
2. Straits Research: Oxaliplatin Market Size, Growth & Revenue Analysis Report | 2032.
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. Sanofi: EFC 7154 - ELoxatin - Summary.
5. Research and Markets: Investigation Report on China's Oxaliplatin Market 2021-2025.