Chemotherapy Administered Every 2 Weeks with or without Pegfilgrastim in Subjects with Advanced or Metastatic Colon Cancer
Study Details
The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing grade 3/4 neutropenia 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.
Protocol Summary
Grade 3 or 4 Neutropenia
Timeframe: First 4 cycles of treatment (8 weeks)
Grade 4 Neutropenia
Timeframe: First 4 cycles of treatment (8 weeks)
Dose Delay or Reduction due to Neutropenia
Timeframe: First 4 cycles of treatment (8 weeks)
Dose Delay or Reduction for Any Reason
Timeframe: First 4 cycles of treatment (8 weeks)
Febrile Neutropenia
Timeframe: First 4 cycles of treatment (8 weeks)
Hospitalization Due to a Neutropenia-Related Event
Timeframe: First 4 cycles of neutropenia (8 weeks)
Progression-Free Survival
Timeframe: Up to 24 months after first four cycles of treatment
Objective Tumor Response
Timeframe: First 4 cycles of treatment (8 weeks)
Survival
Timeframe: Up to 24 months after first four cycles of treatment
Antibiotic Use Due to Febrile Neutropenia
Timeframe: First 4 cycles of treatment (8 weeks)