TerminatedPhase 2

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

Stopped: 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.

France18 participantsStarted 2007-05-01

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 prohi…

What they're measuring

Median Progression-free Survival (PFS) Time

Timeframe: Since surgery, up to 5 years

Trial details

NCT IDNCT00766142

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09-17

Results submitted2020-12-08