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

NCT00766142 | Terminated Phase 2 Results DMC

• 4 other identifiers: IB-2007-20IB-COCHISE-IEUDRACT-2006-003900MERCK-IB-COCHISE-I
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Primary Peritoneal Cavity Cancer

Keywords

adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage IV rectal cancer; peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Median Progression-free Survival (PFS) Time

  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.

  Since surgery, up to 5 years

Secondary Outcomes (3)

• 30-day Mortality Rate

  from the date of surgery up to 30 days

• Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery

  from the date of surgery up to 30 days

• Overall Survival (OS) Time

  from surgery, up to five years.

Study Arms (1)

Chemotherapy + Cetuximab

EXPERIMENTAL

Surgery + Chemotherapy + Cetuximab

Biological: cetuximab; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery

Interventions

cetuximab BIOLOGICAL

Chemotherapy + Cetuximab

fluorouracil DRUG

Chemotherapy + Cetuximab

leucovorin calcium DRUG

Chemotherapy + Cetuximab

oxaliplatin DRUG

Chemotherapy + Cetuximab

adjuvant therapy PROCEDURE

Chemotherapy + Cetuximab

therapeutic conventional surgery PROCEDURE

Chemotherapy + Cetuximab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead
• Assistance Publique - Hôpitaux de Paris: collaborator
• Centre Alexis Vautrin, Nancy: collaborator
• Centre Leon Berard: collaborator
• Institut Cancerologie de l'Ouest: collaborator
• Hôpital Haut-Lévêque: collaborator
• Clinique Médicale de Francheville: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

Related Publications (1)

• Evrard S, Desolneux G, Bellera C, Esnaud T, Becouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pelissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial. BMC Res Notes. 2019 Jul 22;12(1):450. doi: 10.1186/s13104-019-4476-9.

  PMID: 31331370 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Peritoneal Neoplasms

Interventions

Cetuximab; Fluorouracil; Leucovorin; Oxaliplatin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Pr Simone Mathoulin-Pélissier
• Organization: Institut Bergonié

s.mathoulin@bordeaux.unicancer.fr

0556333333

Study Officials

• Serge Evrard

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: May 1, 2007
• Primary Completion: September 17, 2013
• Study Completion: September 17, 2013
• Last Updated: August 29, 2025
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)