FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT00323011
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin (LV) affect blood-clotting factors. A second purpose of this study is to find out what effects the drug dalteparin has on clotting factors in the blood in patients receiving the drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin to chemotherapy may benefit patients with colorectal cancer by preventing blood clots

Key Dates

Start date
May 31, 2006
Status verified
May 2014
Completion
Nov 30, 2007

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: 5-FU/LV/CPT-11/Bevacizumab
    5-FU 400 mg/m2, days 1, 15, \& 29 Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29
  • Experimental: Arm B: 5-FU/LV/CPT-11/Bevacizumab + Dalteparin
    5-FU 400 mg/m2, days 1, 15, \& 29 5-FU 2400 continuous infusion days 1-2, 15-16, 29-30. Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Dalteparin 5000 IU subcutaneous starting cycle 2, days 1, 15, \& 29
  • Experimental: 5-FU/LV/CPT-11/Bevacizumab+Dalteparin daily
    5-FU 400 mg/m2, days 1, 15, \& 29 5-FU 2400 continuous infusion days 1-2, 15-16, 29-30. Leucovorin Calcium 200 mg/m2, days 1, 15, \& 29 CPT-11 180 mg/m2, days 1, 15 \& 29 Bevacizumab 5mg/kg, days 1, 15, \& 29 Dalteparin 5000 IU subcutaneous starting cycle 2, daily

Locations (1)

FacilityCityStateZIPSite coordinators
USCNorris HospitalLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
USCNorris Hospital· Los Angeles, CA

Related Studies