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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012363 |
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 combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II |
| Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 30-55 patients 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 metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 96 Study Locations| Study Chair: | Stephen K. Williamson, MD | University of Kansas |
More Information
| Study ID Numbers: | CDR0000068515, SWOG-S0101 |
| Study First Received: | March 3, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012363 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 squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Irinotecan Stomach Diseases Neoplasms by Site Stomach Neoplasms Therapeutic Uses |
Gemcitabine Digestive System Neoplasms Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic |