Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00016952
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan.

Key Dates

Start date
Apr 30, 2001
Status verified
Dec 2016
Primary completion
Apr 30, 2004
Completion
Oct 31, 2009

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan
    Prior oxaliplatin-based chemotherapy: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years.
  • Experimental: leucovorin + fluorouracil
    Prior to irinotecan and oxaliplatin combination chemotherapy: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion. Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years.

Primary Outcome Measure

tumor response rate [ Time Frame: Up to 5 years ]

Locations (14)

FacilityCityStateZIPSite coordinators
CCOP - Scottsdale Oncology ProgramScottsdaleArizona85259-5404-
Mayo ClinicJacksonvilleFlorida32224-
CCOP - Illinois Oncology Research AssociationPeoriaIllinois61602-
CCOP - Carle Cancer CenterUrbanaIllinois61801-
CCOP - Cedar Rapids Oncology ProjectCedar RapidsIowa52403-1206-
CCOP - Iowa Oncology Research AssociationDes MoinesIowa50309-1016-
Siouxland Hematology-OncologySioux CityIowa51101-1733-
CCOP - WichitaWichitaKansas67214-3882-
CCOP - Ann Arbor RegionalAnn ArborMichigan48106-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106-
Rapid City Regional HospitalRapid CitySouth Dakota57709-
CCOP - Sioux Community Cancer ConsortiumSioux FallsSouth Dakota57104-

Find similar trials in Scottsdale, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
CCOP - Scottsdale Oncology Program· Scottsdale, AZMayo Clinic· Jacksonville, FLCCOP - Illinois Oncology Research Association· Peoria, ILCCOP - Carle Cancer Center· Urbana, ILCCOP - Cedar Rapids Oncology Project· Cedar Rapids, IACCOP - Iowa Oncology Research Association· Des Moines, IA

Related Studies