Study Complete
Sponsor ID
20020715

Chemotherapy Administered Every 2 Weeks with or without Pegfilgrastim in Subjects with Advanced or Metastatic Colon Cancer

Sponsor ID
20020715
Clinicaltrials.gov ID
NCT00094809
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 2
Product
pegfilgrastim
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
252
Additional Study Details

Protocol Summary

Primary Outcome Measures

Grade 3 or 4 Neutropenia

Timeframe: First 4 cycles of treatment (8 weeks)

Grade 4 Neutropenia

Timeframe: First 4 cycles of treatment (8 weeks)

Secondary Outcome Measures

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)

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.