Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Capecitabine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Gemcitabine, Docetaxel, Capecitabine:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

Gemcitabine, Docetaxel, Capecitabine

Robert L Fine, MD

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.

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.

Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)

Data was not analyzed because original PI left institution before data analysis was completed.

Sanofi

Columbia University

AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).

Gemcitabine, Docetaxel, Capecitabine:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

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

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.

Between 30 and 39 years

Between 40 and 49 years

Between 50 and 59 years

Between 60 and 69 years

Between 70 and 79 years

Unknown

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Paul Oberstein

To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer

Determine Overall and One Year Survival Rates

Toxicity Assessment

Overall Study

Spots Global Cancer Trial Database for Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial