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Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer


OBJECTIVES:

Primary

- Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan
hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced
or metastatic colorectal cancer.

Secondary

- Increase the effectiveness of this regimen by intensifying the treatment.

- Specify the constitutional genetic and genomic tumor parameters that could interfere
with and predict the toxicity and/or antitumor efficacy of this regimen.

- Assess the time to progression.

OUTLINE: This is a multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2
hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV
continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence
of disease progression or unacceptable toxicity.

Pharmacokinetic and pharmacogenetic studies are also conducted.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed colorectal cancer

- Advanced or metastatic disease

- Scheduled to receive first- or second-line therapy for metastatic disease

- No cerebral metastases or symptomatic or uncontrolled meningeal disease

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- ANC ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin ≤ 2 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Alkaline phosphatase ≤ 5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No intestinal blockage

- No complete dihydropyrimidine dehydrogenase deficiency

- No chronic inflammatory disease of the colon

- No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of
the cervix or breast

- No other severe condition, or condition that is likely to worsen, including any of
the following:

- Unstable heart disease

- Myocardial infarction within the past 6 months

- Active uncontrolled infection

- No contraindication to atropine

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior anticancer therapy

- More than 4 weeks since prior and no other concurrent investigational therapy

- Prior adjuvant chemotherapy allowed

- No prior fluorouracil or irinotecan hydrochloride

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement of hematologic and gastrointestinal tolerance to therapy

Safety Issue:

Yes

Principal Investigator

Erick Gamelin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

ICO Paul Papin

Authority:

United States: Federal Government

Study ID:

CDR0000574065

NCT ID:

NCT00559741

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • stage IV rectal cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

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