Trials / Completed
CompletedNCT00054457
Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction
A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.
Detailed description
OBJECTIVES: * Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine. * Determine the time to progression in patients treated with this regimen. * Determine the overall survival in patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis. * Assess the quality of life and swallowing uniscale during chemotherapy in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment. Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | capecitabine | |
| DRUG | docetaxel |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2007-02-01
- Completion
- 2008-02-01
- First posted
- 2003-02-06
- Last updated
- 2016-12-13
Locations
28 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00054457. Inclusion in this directory is not an endorsement.