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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 3 years

Safety Issue:

No

Principal Investigator

Serge Evrard

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

Unspecified

Study ID:

CDR0000599511

NCT ID:

NCT00766142

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Peritoneal Cavity Cancer
  • adenocarcinoma of the colon
  • recurrent colon cancer
  • stage IV colon cancer
  • adenocarcinoma of the rectum
  • recurrent rectal cancer
  • stage IV rectal cancer
  • peritoneal carcinomatosis
  • Colorectal Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma

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