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

Colorectal Cancer Clinical Trial

— COCHISE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766142
• Other study ID #: CDR0000599511
• Secondary ID: IB-COCHISE-IIB-2
• Status: Terminated
• Phase: Phase 2
• Start date: May 1, 2007
• Est. completion date: September 17, 2013

Study information

• Verified date: January 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 17, 2013
• Est. primary completion date: September 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• cetuximab

Drug:
• fluorouracil

• leucovorin calcium

• oxaliplatin

Procedure:
• adjuvant therapy

• therapeutic conventional surgery

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (7)

Lead Sponsor	Collaborator
Institut Bergonié	Assistance Publique - Hôpitaux de Paris, Centre Alexis Vautrin, Nancy, Centre Leon Berard, Clinique Francheville, Périgueux, Hôpital Haut-Lévêque, Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

References & Publications (1)

Evrard S, Desolneux G, Bellera C, Esnaud T, Bécouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pélissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-day Mortality Rate	Rate of deaths observed within 30 days of surgery	from the date of surgery up to 30 days
Secondary	Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery		from the date of surgery up to 30 days
Secondary	Overall Survival (OS) Time	OS is the delay between surgery and death	from surgery, up to five years.