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| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00020761 |
Purpose
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 irinotecan and paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: irinotecan hydrochloride Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract |
| Enrollment: | 51 |
| Study Start Date: | April 2000 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gastro Esophogeal cohort
Patients with adenocarcinoma of the esophagus, gastroesophageal (GE) junction and gastric cardia (GE cohort) The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks. |
Drug: irinotecan hydrochloride
The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks. The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks. |
|
Experimental: Distal Stomach cohort
Patients with adenocarcinoma of the rest of the stomach (Distal Stomach cohort) The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks. |
Drug: irinotecan hydrochloride
The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks. The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks. |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs adenocarcinoma of the rest of the stomach).
Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 26-54 patients (13-27 per stratum) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| United States, Oregon | |
| OHSU Cancer Institute | |
| Portland, Oregon, United States, 97201-3098 | |
| Study Chair: | Joel R. Hecht, MD | Jonsson Comprehensive Cancer Center |
More Information
| Responsible Party: | Randolph Hecht, MD / Principal Investigator, UCLA |
| ClinicalTrials.gov Identifier: | NCT00020761 History of Changes |
| Other Study ID Numbers: | CDR0000068711, P30CA016042, UCLA-0001048, NCI-G01-1957 |
| Study First Received: | July 11, 2001 |
| Last Updated: | March 1, 2010 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
|
stage IV gastric cancer recurrent gastric cancer stage IV esophageal cancer |
recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
|
Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Stomach Diseases |
Paclitaxel Irinotecan Camptothecin Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors |