Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim (Neulasta) in Subjects With Advanced Colon Cancer
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colon Cancer; Colorectal Cancer; Rectal Cancer
Intervention: Neulasta® (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Summary
The purpose of this research study is to evaluate the safety and effectiveness of
pegfilgrastim in reducing infection when given after one of three chemotherapy regimens
(FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer.
This study is considered to be "investigational" because the time between receiving
pegfilgrastim and the next cycle of chemotherapy is only 11 days.
Clinical Details
Official title: Chemotherapy Administered Every 2 Weeks With or Without a Single Injection of Pegfilgrastim as First or Second-Line Treatment in Subjects With Locally Advanced or Metastatic Colon Cancer
Study design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Grade 3 and 4 neutropenia in the first 4 cycles of treatment
Secondary outcome: Dose delaysDose reductions Quality of life as measured by FACT-N, FACT-C subscale, and HADS Febrile neutropenia Hospitalization rates due to a neutropenia-related event Objective response rates Time to progression Survival
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: - Diagnosis of advanced or metastatic colon cancer - Have not had any surgery within the past 2 weeks - Have not received radiation therapy within the past 4 weeks - No more than one prior chemotherapy regimen
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: February 2003
Last updated: December 20, 2007
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