Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

February 1, 2003

Primary Completion Date

May 19, 2006

Study Completion Date

January 23, 2008

Conditions
Colon CancerColorectal CancerRectal Cancer
Interventions
DRUG

Placebo

Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.

DRUG

Pegfilgrastim

Subjects randomized to pegfilgrastim will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY