Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|