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Phase I/II Study of 5-Fluorouracil/Folinic Acid/Gemcitabine in Patients With Advanced Colorectal Carcinoma


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase I/II Study of 5-Fluorouracil/Folinic Acid/Gemcitabine in Patients With Advanced Colorectal Carcinoma


OBJECTIVES: I. Determine the response rate and survival of patients with recurrent or
metastatic colorectal carcinoma treated with fluorouracil (5-FU), leucovorin calcium, and
gemcitabine. II. Evaluate and establish the toxic effect profile of 5-FU, leucovorin
calcium, and gemcitabine in these patients.

OUTLINE: This is a dose escalation study. Patients receive intravenous leucovorin calcium
for 60 minutes and bolus infusions of fluorouracil (5-FU), followed by gemcitabine
infusions, weekly for six weeks followed by 2 weeks of rest. The dosage of gemcitabine is
increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. Phase II
proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients
experience grade 3-4 toxicities). Patients receive a minimum of two courses of treatment to
be considered evaluable for response. Patients with stable disease, partial, or complete
remission may continue therapy for up to six treatment cycles. Patients exhibiting disease
progression or intolerable toxic effects are removed from the study.

PROJECTED ACCRUAL: A total of 63 patients will be accrued.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic primary colorectal
carcinoma Must have measurable disease (evaluable disease acceptable in Phase I)

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-3 Life Expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3
Hepatic: Bilirubin no greater than 1.5 mg/dL OR 3.0 mg/dL in patients with liver
metastases Liver enzymes no greater than 3.0 times upper limit of normal (in patients with
liver metastases) Renal: Not specified Other: Not pregnant or lactating Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
for metastatic disease allowed Prior treatment with 5-FU allowed Prior treatment with
irinotecan allowed Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since
prior radiotherapy (measurable disease must be located outside the prior radiotherapy
portal) Surgery: Not specified Other: Prior treatment with folinic acid allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stefan Madajewicz, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Stony Brook University

Authority:

United States: Federal Government

Study ID:

CDR0000065561

NCT ID:

NCT00003001

Start Date:

April 1997

Completion Date:

Related Keywords:

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

Name

Location
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775