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Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer (COCHISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00766142
Recruitment Status : Terminated (In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.)
First Posted : October 3, 2008
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Centre Alexis Vautrin, Nancy
Centre Leon Berard
Institut Cancerologie de l'Ouest
Hôpital Haut-Lévêque
Clinique Francheville, Périgueux
Information provided by (Responsible Party):
Institut Bergonié

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Primary Peritoneal Cavity Cancer Biological: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis of colorectal origin.

Secondary

  • Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy.
  • Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients.
  • Determine the overall tolerability (mortality, morbidity) of this regimen, including surgery, in these patients.

OUTLINE: This is a multicenter study.

Patients undergo complete resection of the peritoneal carcinomatosis. Beginning 4-8 weeks after surgery, patients receive cetuximab IV over 2.5 hours. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Treatment repeats every 2 weeks for up to 12 courses.

After completion of study therapy, patients are followed every 4 months for 2 years and then every 6 months for 3 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin
Study Start Date : May 1, 2007
Actual Primary Completion Date : September 17, 2013
Actual Study Completion Date : September 17, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherapy + Cetuximab
Surgery + Chemotherapy + Cetuximab
 Biological: cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery


Outcome Measures
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Primary Outcome Measures :
  1. Median Progression-free Survival (PFS) Time [ Time Frame: Since surgery, up to 5 years ]

    Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.



Secondary Outcome Measures :
  1. 30-day Mortality Rate [ Time Frame: from the date of surgery up to 30 days ]
    Rate of deaths observed within 30 days of surgery

  2. Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery [ Time Frame: from the date of surgery up to 30 days ]
  3. Overall Survival (OS) Time [ Time Frame: from surgery, up to five years. ]
    OS is the delay between surgery and death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal adenocarcinoma meeting the following criteria:

    • Exclusively peritoneal carcinomatosis (no other metastases)
    • Resectable disease
  • Primary tumor may be same in the same location as another synchronous carcinomatosis
  • Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Creatinine ≤ 1.25 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil
  • No other noncancerous disease that would preclude study therapy
  • Good nutritional status
  • No sensitive peripheral neuropathy with functional impairment
  • No hypoplasia or bone marrow failure
  • No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction)
  • No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer
  • No patients deprived of liberty or under supervision
  • No psychological, social, familial, or geographical reasons prohibiting follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab
  • No prophylactic phenytoin (Dihydan®, Dilantin®)
  • No prior yellow fever vaccine
  • More than 1 month since participation in another study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766142


Locations
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France
Institut Bergonie
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Assistance Publique - Hôpitaux de Paris
Centre Alexis Vautrin, Nancy
Centre Leon Berard
Institut Cancerologie de l'Ouest
Hôpital Haut-Lévêque
Clinique Francheville, Périgueux
Investigators
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Study Chair: Serge Evrard Institut Bergonié
More Information
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Publications of Results:

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT00766142    
Other Study ID Numbers: CDR0000599511
IB-COCHISE-I ( Other Identifier: Institut Bergonié )
IB-2007-20 ( Other Identifier: Institut Bergonié )
EUDRACT-2006-003900 ( Registry Identifier: EUDRACT )
MERCK-IB-COCHISE-I ( Other Identifier: MERCK )
First Posted: October 3, 2008    Key Record Dates
Results First Posted: January 26, 2021
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer
adenocarcinoma of the rectum
 recurrent rectal cancer
stage IV rectal cancer
peritoneal carcinomatosis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Carcinoma
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Abdominal Neoplasms
Peritoneal Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Cetuximab
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents