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Last Updated: January 21, 2021

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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 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.
>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 Unknown status 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.
NCT00003902 Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement Completed Swiss Group for Clinical Cancer Research Phase 1/Phase 2 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: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.
NCT00004012 Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Completed National Cancer Institute (NCI) Phase 2 1998-12-01 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 recurrent ovarian, fallopian tube, or primary peritoneal cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Capecitabine

Condition Name

Condition Name for Capecitabine
Intervention Trials
Breast Cancer 197
Colorectal Cancer 153
Gastric Cancer 101
Metastatic Breast Cancer 72
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Condition MeSH

Condition MeSH for Capecitabine
Intervention Trials
Breast Neoplasms 355
Colorectal Neoplasms 287
Stomach Neoplasms 181
Rectal Neoplasms 160
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Clinical Trial Locations for Capecitabine

Trials by Country

Trials by Country for Capecitabine
Location Trials
China 323
Italy 253
Spain 191
Canada 187
United Kingdom 164
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Trials by US State

Trials by US State for Capecitabine
Location Trials
California 165
Texas 149
New York 139
Florida 120
Pennsylvania 111
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Clinical Trial Progress for Capecitabine

Clinical Trial Phase

Clinical Trial Phase for Capecitabine
Clinical Trial Phase Trials
Phase 4 23
Phase 3 258
Phase 2/Phase 3 43
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Clinical Trial Status

Clinical Trial Status for Capecitabine
Clinical Trial Phase Trials
Completed 495
Recruiting 295
Not yet recruiting 195
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Clinical Trial Sponsors for Capecitabine

Sponsor Name

Sponsor Name for Capecitabine
Sponsor Trials
National Cancer Institute (NCI) 166
Hoffmann-La Roche 130
Sanofi 59
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Sponsor Type

Sponsor Type for Capecitabine
Sponsor Trials
Other 1479
Industry 703
NIH 168
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