Trials / Completed
CompletedNCT00040859
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (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 the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
Detailed description
OBJECTIVES: Primary * Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine. Secondary * Determine the time to progression and overall survival of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Assess the quality of life of patients treated with this regimen. OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | capecitabine | |
| DRUG | oxaliplatin |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2005-01-01
- Completion
- 2008-04-01
- First posted
- 2003-01-27
- Last updated
- 2016-12-07
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00040859. Inclusion in this directory is not an endorsement.