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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
252
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.
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.
Grade 3 or 4 Neutropenia
Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) \< 1 x 10\^9/L, in any of the first four cycles of treatment
Time frame: First 4 cycles of treatment (8 weeks)
Grade 4 Neutropenia
Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) \<0.5 x 10\^9/L, in any of the first four cycles of treatment
Time frame: First 4 cycles of treatment (8 weeks)
Dose Delay or Reduction Due to Neutropenia
Dose delay or reduction in chemotherapy doses due to neutropenia
Time frame: First 4 cycles of treatment (8 weeks)
Dose Delay or Reduction for Any Reason
Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason
Time frame: First 4 cycles of treatment (8 weeks)
Febrile Neutropenia
Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC \< 1.0 x 10\^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.
Time frame: First 4 cycles of treatment (8 weeks)
Hospitalization Due to a Neutropenia-Related Event
Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment
Time frame: First 4 cycles of neutropenia (8 weeks)
Progression-Free Survival
Kaplan-Meier estimate of the median time to disease progression or death
Time frame: Up to 24 months after first four cycles of treatment
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Objective Tumor Response
Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.
Time frame: First 4 cycles of treatment (8 weeks)
Survival
Death from any cause through the end of the follow-up period
Time frame: Up to 24 months after first four cycles of treatment
Antibiotic Use Due to Febrile Neutropenia
Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.
Time frame: First 4 cycles of treatment (8 weeks)