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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00268333
First received: December 20, 2005
Last updated: February 6, 2009
Last verified: May 2007
  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 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Laurent Mineur, MD Institut Sainte Catherine
  More Information

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
Oxaliplatin
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on October 01, 2014