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

NCT ID: NCT00268333

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31

Brief 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.

Detailed Description

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Laurent Mineur, MD

Role: STUDY_CHAIR

Institut Sainte Catherine

Locations

Institut Sainte Catherine

Avignon, , France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, , France

Hopital Drevon

Dijon, , France

Hopital Robert Boulin

Libourne, , France

Polyclinique des Quatre Pavillons

Lormont, , France

Hopital Europeen Georges Pompidou

Paris, , France

Hopital Tenon

Paris, , France

Polyclinique De Courlancy

Reims, , France

C.H. Senlis

Senlis, , France

Countries

France

Other Identifiers

GERCOR-C04-1

Identifier Type: -

Identifier Source: secondary_id

EU-20568

Identifier Type: -

Identifier Source: secondary_id

SANOFI-GERCOR-C04-1

Identifier Type: -

Identifier Source: secondary_id

CDR0000453784

Identifier Type: -

Identifier Source: org_study_id