Trials / Completed
CompletedNCT00084617
Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).
Detailed description
PRIMARY OBJECTIVES: I. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma. II. To assess the duration of total responses of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma. OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients are followed annually. PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18 months.
Conditions
- Adenocarcinoma of the Gastroesophageal Junction
- Diffuse Adenocarcinoma of the Stomach
- Intestinal Adenocarcinoma of the Stomach
- Mixed Adenocarcinoma of the Stomach
- Recurrent Gastric Cancer
- Stage IIIA Gastric Cancer
- Stage IIIB Gastric Cancer
- Stage IIIC Gastric Cancer
- Stage IV Gastric Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | oxaliplatin | Given IV |
| DRUG | irinotecan hydrochloride | Given IV |
| DRUG | capecitabine | Given orally |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2008-10-01
- Completion
- 2008-12-01
- First posted
- 2004-06-11
- Last updated
- 2015-05-01
- Results posted
- 2015-05-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00084617. Inclusion in this directory is not an endorsement.