Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
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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 oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia |
- Clinical response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | February 2000 |
| Study Completion Date: | August 2003 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Oxaliplatin (85 mg/m2, day 1 of every 14 day cycle), Leucovorin (500 mg/m2, day 1 and 2 of every 14 day cycle), Fluorouracil (Bolus of 400 mg/m2 followed by 22 hr continuous infusion of 600 mg/m2 on days 1 and 2 of every 14 day cycle)
|
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Detailed Description:
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin, fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall survival of this patient population receiving this regimen. III. Determine the toxicity, including neurotoxicity, of this regimen in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive at least 3 additional courses of therapy. Patients are followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the esophagus or gastric cardia Stage IV or recurrent Bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin normal SGOT less than 2 times upper limit of normal (ULN) Renal: BUN less than 1.5 times ULN Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure No unstable angina pectoris No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics appropriate for study No uncontrolled concurrent illness No active infection No clinical evidence of peripheral neuropathy by physical exam or history
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors during the first course of study Chemotherapy: More than 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for carcinoma of the esophagus or gastric cardia No prior fluorouracil Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy in HIV-positive patients No other concurrent anticancer agents
Contacts and Locations| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Cancer Care Specialists of Central Illinois, S.C. | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Columbia LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Michiana Hematology/Oncology P.C. | |
| South Bend, Indiana, United States, 46617 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| Lakeland Medical Center - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Grant/Riverside Methodist Hospitals | |
| Columbus, Ohio, United States, 43214 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Ann M. Mauer, MD | University of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00004127 History of Changes |
| Other Study ID Numbers: | 10015, UCCRC-10015, NCI-T99-0010 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Chicago:
|
stage IV gastric cancer recurrent gastric cancer stage IV esophageal cancer |
recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Stomach Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013