A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas.

University of Pittsburgh1 site in 1 country40 target enrollmentApril 2005

Overview

Brief Summary

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.

Detailed Description

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

December 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Pittsburgh

Responsible Party

Principal Investigator

Nathan Bahary, MD

Associate Professor, Department of Medicine, Division of Oncology

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

•Have histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric, gastro-esophageal, or esophageal origin.
•Must have measurable or evaluable disease.
•Received adjuvant therapy are eligible if adjuvant therapy was given ≥ 6 months prior to the diagnosis of metastatic disease.
•Life expectancy greater than 12 weeks.
•ECOG performance status \<
•Adequate organ and marrow function.
•Preexisting peripheral neuropathy if present must be grade 0 or
•Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 3 months thereafter. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria

•No chemotherapy or radiotherapy within 4 weeks
•Not receiving any other investigational agents or participate in any investigational drug study within 4 weeks preceding the start of study treatment.
•Patients with known brain metastases shall be excluded from this clinical trial
•Patients with evidence or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant that precludes informed consent or interferes with the compliance of oral drug intake will also be excluded.
•History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, capecitabine or 5-FU.
•Uncontrolled intercurrent illness
•Pregnant or breast feeding women are excluded from this study
•Inability to swallow tablets or those who have malabsorptive symptoms will be excluded.
•HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel or capecitabine.

Arms & Interventions

Docetaxel + Capecitabine

Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22. Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14). Each cycle will consist of 21 days. Cycle 2 will begin on day 22.

Intervention: Docetaxel

Docetaxel + Capecitabine

Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22. Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14). Each cycle will consist of 21 days. Cycle 2 will begin on day 22.

Intervention: Capecitabine