Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Alliance for Clinical Trials in Oncology
- Study ID
- NCT00004235
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- docetaxel — DRUG
- irinotecan hydrochloride — DRUG
Study Details
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and irinotecan in treating patients who have advanced cancer of the esophagus or stomach.
Key Dates
- Start date
- Jan 31, 2000
- Status verified
- Jul 2016
- Primary completion
- Aug 31, 2004
- Completion
- Aug 31, 2004
Study Design
- Enrollment
- 47 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: irinotecan + docetaxelPatients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response (CR) receive 2 additional courses after CR. Patients experiencing disease progression after a CR and 2 additional courses may be retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are assessed before the first course of treatment and then at each tumor assessment. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Primary Outcome Measure
objective tumor response rate [ Time Frame: Up to 5 years ]
Locations (18)
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