Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer - Full Text View

Sponsored by:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00268333

Purpose

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

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)

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268333

Locations

France
C.H. Senlis
Senlis, France, 60309
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Drevon
Dijon, France, 21000
Hopital Europeen Georges Pompidou
Paris, France, 75015
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Hopital Tenon
Paris, France, 75970
Institut Sainte Catherine
Avignon, France, 84082
Polyclinique De Courlancy
Reims, France, F-51100
Hopital Robert Boulin
Libourne, France, 33500

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Study Chair:

Laurent Mineur, MD

Institut Sainte Catherine

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000453784, GERCOR-C04-1, EU-20568, SANOFI-GERCOR-C04-1
Study First Received:	December 20, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00268333
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

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms

Rectal neoplasm
Calcium, Dietary
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 15, 2009