Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or rectum

• Metastatic disease isolated to the following lymph nodes:

• Aortic

• Interaortic

• Celiomesenteric

• Retroperitoneal, including the following sites:

• Peri-uretal

• Liver

• Iliac

• Clavicle

• Mediastinum

• Inguinal

• Cervical

• Incompletely resected disease

• Recurrent disease, defined by 1 of the following criteria:

• Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin

• Progressive disease after cisplatin or fluorouracil

• Must be able to be encompassed in radiation field

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

• Life expectancy more than 12 weeks

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000 /mm^3

• Alkaline phosphatase ≤ 5 times normal

• Bilirubin ≤ 2 times normal

• Creatinine < 2 times normal or creatinine clearance ≥ 40 mL/min

• No peripheral neuropathy > grade 1

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No weight loss > 15% since diagnosis of recurrent disease

• No uncontrolled heart disease

• No angina

• No symptomatic disease of the inferior artery

• No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or radiotherapy

• No concurrent corticosteroids