Clinical trial NCT00766142: Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Centre Alexis Vautrin, Nancy
name: Centre Leon Berard
name: Institut Cancerologie de l'Ouest
name: Hôpital Haut-Lévêque
name: Clinique Médicale de Francheville
First posted: 2008-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Median Progression-free Survival (PFS) Time
timeFrame: Since surgery, up to 5 years
Secondary outcomes:
measure: 30-day Mortality Rate
timeFrame: from the date of surgery up to 30 days
measure: Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery
timeFrame: from the date of surgery up to 30 days
measure: Overall Survival (OS) Time
timeFrame: from surgery, up to five years.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
affiliation: Institut Bergonié
name: Serge Evrard
role: STUDY_CHAIR
References:
citation: 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.