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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radiotherapy and concurrent fluorouracil and oxaliplatin. Secondary Determine the overall survival and disease-free survival of patients treated with this regimen. Determine the primary site of recurrence and time to recurrence in patients treated with this regimen. Determine quality of life of patients treated with this regimen. OUTLINE: This is a nonrandomized, open-label, multicenter study. Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients with stable or responding disease proceed to chemoradiotherapy. Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5 weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks beginning on day 1. Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the completion of study treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Official Title
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Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: leucovorin calcium
* Drug: oxaliplatin
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Drug: oxaliplatin|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Disease-free survival |  |  | 
| Primary site of recurrence |  |  | 
| Time to recurrence |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage III colon cancer, stage III rectal cancer, stage IV rectal cancer