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Last Updated: August 7, 2020

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CLINICAL TRIALS PROFILE FOR XELODA

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505(b)(2) Clinical Trials for Xeloda

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 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 Xeloda

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.
NCT00004183 Capecitabine in Treating Patients With Malignant Mesothelioma Completed National Cancer Institute (NCI) Phase 2 2000-11-01 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 malignant mesothelioma.
NCT00004183 Capecitabine in Treating Patients With Malignant Mesothelioma Completed Alliance for Clinical Trials in Oncology Phase 2 2000-11-01 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 malignant mesothelioma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Xeloda

Condition Name

Condition Name for Xeloda
Intervention Trials
Breast Cancer 56
Colorectal Cancer 44
Gastric Cancer 21
Rectal Cancer 14
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Condition MeSH

Condition MeSH for Xeloda
Intervention Trials
Breast Neoplasms 81
Colorectal Neoplasms 74
Stomach Neoplasms 35
Rectal Neoplasms 34
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Clinical Trial Locations for Xeloda

Trials by Country

Trials by Country for Xeloda
Location Trials
United States 453
China 65
Spain 60
Canada 51
Brazil 31
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Trials by US State

Trials by US State for Xeloda
Location Trials
New York 30
Texas 30
California 29
Florida 25
Tennessee 18
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Clinical Trial Progress for Xeloda

Clinical Trial Phase

Clinical Trial Phase for Xeloda
Clinical Trial Phase Trials
Phase 4 8
Phase 3 50
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Xeloda
Clinical Trial Phase Trials
Completed 142
Recruiting 43
Unknown status 40
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Clinical Trial Sponsors for Xeloda

Sponsor Name

Sponsor Name for Xeloda
Sponsor Trials
Hoffmann-La Roche 76
National Cancer Institute (NCI) 27
Sanofi 16
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Sponsor Type

Sponsor Type for Xeloda
Sponsor Trials
Other 273
Industry 171
NIH 27
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