Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
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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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: neoadjuvant therapy |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
Official Title: | 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 |
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Primary site of recurrence [ Designated as safety issue: No ]
- Time to recurrence [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
Estimated Enrollment: | 39 |
Study Start Date: | August 2005 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
France | |
Institut Sainte Catherine | |
Avignon, France, 84082 | |
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | |
Besancon, France, 25030 | |
Hopital Drevon | |
Dijon, France, 21000 | |
Hopital Robert Boulin | |
Libourne, France, 33500 | |
Polyclinique des Quatre Pavillons | |
Lormont, France, 33310 | |
Hopital Tenon | |
Paris, France, 75970 | |
Hopital Europeen Georges Pompidou | |
Paris, France, 75015 | |
Polyclinique De Courlancy | |
Reims, France, F-51100 | |
C.H. Senlis | |
Senlis, France, 60309 |
Study Chair: | Laurent Mineur, MD | Institut Sainte Catherine |
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00268333 History of Changes |
Other Study ID Numbers: | CDR0000453784, GERCOR-C04-1, EU-20568, SANOFI-GERCOR-C04-1 |
Study First Received: | December 20, 2005 |
Last Updated: | February 6, 2009 |
Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon adenocarcinoma of the rectum stage IV colon cancer |
stage III colon cancer stage III rectal cancer stage IV rectal cancer |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal 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 October 16, 2012