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Last Updated: June 13, 2024

CLINICAL TRIALS PROFILE FOR CAPECITABINE


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505(b)(2) Clinical Trials for Capecitabine

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 NCT00230399 ↗ Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer Completed University of Michigan Cancer Center Phase 2 2003-06-01 This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two 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 of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination NCT00230399 ↗ Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer Completed University of Michigan Rogel Cancer Center Phase 2 2003-06-01 This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two 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 of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Capecitabine

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.
NCT00003867 ↗ Irinotecan and Capecitabine in Treating Patients With Solid Tumors Completed National Cancer Institute (NCI) Phase 1 1999-03-01 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. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003867 ↗ Irinotecan and Capecitabine in Treating Patients With Solid Tumors Completed Albert Einstein College of Medicine of Yeshiva University Phase 1 1999-03-01 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. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003867 ↗ Irinotecan and Capecitabine in Treating Patients With Solid Tumors Completed Montefiore Medical Center Phase 1 1999-03-01 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. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Capecitabine

Condition Name

Condition Name for Capecitabine
Intervention Trials
Breast Cancer 234
Colorectal Cancer 170
Gastric Cancer 129
Rectal Cancer 86
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Condition MeSH

Condition MeSH for Capecitabine
Intervention Trials
Breast Neoplasms 436
Colorectal Neoplasms 344
Stomach Neoplasms 220
Adenocarcinoma 205
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Clinical Trial Locations for Capecitabine

Trials by Country

Trials by Country for Capecitabine
Location Trials
China 645
Italy 357
Japan 329
Spain 315
Taiwan 83
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Trials by US State

Trials by US State for Capecitabine
Location Trials
California 222
Texas 193
New York 185
Florida 154
Pennsylvania 142
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Clinical Trial Progress for Capecitabine

Clinical Trial Phase

Clinical Trial Phase for Capecitabine
Clinical Trial Phase Trials
Phase 4 24
Phase 3 328
Phase 2/Phase 3 55
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Clinical Trial Status

Clinical Trial Status for Capecitabine
Clinical Trial Phase Trials
Completed 688
Recruiting 319
Unknown status 211
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Clinical Trial Sponsors for Capecitabine

Sponsor Name

Sponsor Name for Capecitabine
Sponsor Trials
National Cancer Institute (NCI) 185
Hoffmann-La Roche 138
Sanofi 62
[disabled in preview] 100
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Sponsor Type

Sponsor Type for Capecitabine
Sponsor Trials
Other 1974
Industry 922
NIH 188
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