Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Condition: Colorectal Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Colorectal Neoplasms; Carcinoma; Peritoneal Neoplasms
Intervention: cetuximab; fluorouracil; leucovorin calcium; oxaliplatin; adjuvant therapy; therapeutic conventional surgery
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Cetuximab; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

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