Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT00022698
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

Key Dates

Start date
May 31, 2001
Status verified
Feb 2005
Primary completion
Dec 31, 2004
Completion
Dec 31, 2004

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1,Initial Regimen:(Capecitabine + Irinotecan )
    Participants will receive capecitabine (Xeloda) 1000 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
  • Experimental: Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)
    Participants will receive capecitabine 900 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).

Primary Outcome Measure

Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0) [ Time Frame: Approximately 43 Months ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Comprehensive Cancer CenterBirminghamAlabama35294-3300-
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma LindaCalifornia92354-
Eastern Connecticut Hematology and Oncology AssociatesNorwichConnecticut06360-
George Washington University Medical CenterWashington D.C.District of Columbia20037-
Lombardi Cancer Center at Georgetown University Medical CenterWashington D.C.District of Columbia20007-
University of Florida Health Science Center - JacksonvilleJacksonvilleFlorida32209-
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexingtonKentucky40536-0084-
St. Louis University Hospital Cancer CenterSt LouisMissouri63110-0250-
HemOnCare, P.C.BrooklynNew York11235-
Lincoln Medical and Mental Health CenterThe BronxNew York10451-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphiaPennsylvania19107-5541-
Charleston Hematology-Oncology, P.A.CharlestonSouth Carolina29403-
Cancer Center at the University of VirginiaCharlottesvilleVirginia22908-
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattleWashington98104-
Rockwood Clinic P.S.SpokaneWashington99202-
West Virginia University HospitalsMorgantownWest Virginia26506-9300-

Find similar trials in Birmingham, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Alabama at Birmingham Comprehensive Cancer Center· Birmingham, ALLoma Linda University Cancer Institute at Loma Linda University Medical Center· Loma Linda, CAEastern Connecticut Hematology and Oncology Associates· Norwich, CTGeorge Washington University Medical Center· Washington D.C., DCLombardi Cancer Center at Georgetown University Medical Center· Washington D.C., DCUniversity of Florida Health Science Center - Jacksonville· Jacksonville, FL

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