Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

July 23, 2008 updated by: Stony Brook University

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11790-7775
        • State University of New York Health Sciences Center - Stony Brook

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Study Chair: Stefan Madajewicz, MD, PhD, Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 28, 2004

First Posted (Estimate)

April 29, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

April 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065561
  • SUNY-HSC-97-2824
  • NCI-V97-1256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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