Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer
|ClinicalTrials.gov Identifier: NCT00165464|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer GE Junction Cancer||Drug: Taxotere Drug: Cisplatin Drug: Irinotecan||Phase 2|
- Taxotere, cisplatin and irinotecan will be administered to the patient once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks).
- Patients will also receive corticosteroids, intravenous hydration and anti-emetic therapy prior to each treatment.
- A physical exam and bloodwork will be done each week of the treatment and every 2 cycles, reassessment of the tumor by the same imaging method to determine the baseline size will be conducted.
- Patients will remain on the study unless disease progression or intolerable toxicity occur.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||April 2009|
- To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).
- To assess the duration of response and overall survival of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan.
- To assess the toxicity of this combination in esophageal or gastric carcinoma. [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165464
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Peter C. Enzinger, MD||Dana-Farber Cancer Institute|