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Last Updated: May 30, 2020

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CLINICAL TRIALS PROFILE FOR OXALIPLATIN

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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.
New Combination NCT00531245 A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer Completed Samsung Medical Center Phase 1/Phase 2 2006-08-01 Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin. Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then, in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of the new combination regimen in advanced colorectal cancer.
New Combination NCT01196260 Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Unknown status Beihua University Phase 2/Phase 3 2004-01-01 This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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 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.
NCT00003427 Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer Completed National Cancer Institute (NCI) Phase 1 1998-04-01 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. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.
NCT00003427 Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer Completed Memorial Sloan Kettering Cancer Center Phase 1 1998-04-01 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. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.
NCT00003594 Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Completed National Cancer Institute (NCI) Phase 3 1998-10-01 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 most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Oxaliplatin

Condition Name

Condition Name for Oxaliplatin
Intervention Trials
Colorectal Cancer 278
Gastric Cancer 122
Metastatic Colorectal Cancer 103
Pancreatic Cancer 71
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Condition MeSH

Condition MeSH for Oxaliplatin
Intervention Trials
Colorectal Neoplasms 570
Adenocarcinoma 254
Stomach Neoplasms 223
Pancreatic Neoplasms 156
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Clinical Trial Locations for Oxaliplatin

Trials by Country

Trials by Country for Oxaliplatin
Location Trials
China 308
Australia 84
Belgium 55
Taiwan 50
Austria 42
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Trials by US State

Trials by US State for Oxaliplatin
Location Trials
California 176
New York 151
Texas 127
Ohio 126
Pennsylvania 119
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Clinical Trial Progress for Oxaliplatin

Clinical Trial Phase

Clinical Trial Phase for Oxaliplatin
Clinical Trial Phase Trials
Phase 4 21
Phase 3 261
Phase 2/Phase 3 44
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Clinical Trial Status

Clinical Trial Status for Oxaliplatin
Clinical Trial Phase Trials
Completed 518
Recruiting 378
Not yet recruiting 211
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Clinical Trial Sponsors for Oxaliplatin

Sponsor Name

Sponsor Name for Oxaliplatin
Sponsor Trials
National Cancer Institute (NCI) 235
Sanofi 126
Hoffmann-La Roche 60
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Sponsor Type

Sponsor Type for Oxaliplatin
Sponsor Trials
Other 1657
Industry 674
NIH 236
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