Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00052585
Phase
PHASE2
Status
Terminated

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • irinotecan hydrochloride — DRUG
    Given IV
  • gefitinib — DRUG
    Given orally
  • leucovorin calcium — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV

Study Details

Phase II trial to study the effectiveness of combining gefitinib with fluorouracil, leucovorin, and irinotecan in treating patients who have advanced or recurrent colorectal cancer. Biological therapies such as gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with fluorouracil, leucovorin, and irinotecan may kill more tumor cells

Key Dates

Start date
Oct 31, 2002
Status verified
Jan 2013
Primary completion
Nov 30, 2004

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (irinotecan, gefitinib, leucovorin, fluorouracil)
    Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Grade 3 or 4 toxicity, graded using the NCI CTC version 2.0 [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of The University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Abramson Cancer Center of The University of Pennsylvania· Philadelphia, PA

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