ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00026364
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic colorectal cancer. Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ZD 1839 with combination chemotherapy may kill more tumor cells.

Key Dates

Start date
Nov 30, 2001
Status verified
Sep 2002
Primary completion
Dec 31, 2006

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive oral ZD 1839 daily. Beginning on day 15, patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15 minutes, and fluorouracil IV weekly on weeks 1-2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ZD 1839 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are accrued to receive treatment at the MTD.

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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