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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| 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: | Treatment |
| Official Title: | A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract |
| Study Start Date: | April 2000 |
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the esophagus (including the gastroesophageal junction) or stomach
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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
| Study ID Numbers: | CDR0000068711, UCLA-0001048, NCI-G01-1957 |
| Study First Received: | July 11, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00020761 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV gastric cancer recurrent gastric cancer stage IV esophageal cancer |
recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
|
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Irinotecan Esophageal Cancer Antimitotic Agents Camptothecin Recurrence Carcinoma Digestive System Diseases Stomach Diseases |
Paclitaxel Esophageal Disorder Stomach Neoplasms Head and Neck Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Stomach Cancer Esophageal Diseases Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
|
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Irinotecan Neoplasms by Site Stomach Diseases Therapeutic Uses Stomach Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents |
Camptothecin Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Paclitaxel Head and Neck Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |