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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00996333 |
Purpose
This study is designed to determine whether an investigational drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Cancer |
Drug: Gemcitabine, Docetaxel, Capecitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX) |
| Enrollment: | 45 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemzar, Taxotere, Xeloda
Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
|
Drug: Gemcitabine, Docetaxel, Capecitabine
1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11 This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles. Other Names:
|
This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic cancer. It will further determine the overall and one year survival rates, the diseasefree interval, and the toxicities for this regimen in patients with metastatic pancreatic cancer.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following lesions conventionally are not considered measurable:
Prior radiation and surgery allowed:
Clinical Parameters:
Required initial laboratory data:
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Robert L Fine, MD | Columbia University |
More Information
| Responsible Party: | Robert L. Fine M.D., Columbia University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00996333 History of Changes |
| Other Study ID Numbers: | AAAB8628 |
| Study First Received: | October 14, 2009 |
| Last Updated: | April 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Stage IVB |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine Docetaxel Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |