Conditions: Cancer Colon Cancer Colorectal Cancer Fever Locally Advanced Metastatic Colorectal Cancer Neutropenia Rectal Cancer
Keywords: adenocarcinoma of the colon or rectum febrile neutropenia Bevacizumab Avastin 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 847
Healthy volunteers: no

Brief summary:
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).

This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

Detailed description:

Arms:
arm 1: Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). arm 2: Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).

Interventions: intervention 1: Pegfilgrastim intervention 2: Placebo intervention 3: Bevacizumab intervention 4: Standard Chemotherapy
Intervention descriptions: intervention 1: Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product. intervention 2: Administered as a single subcutaneous injection using a pre-filled syringe. intervention 3: 5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle. intervention 4: Each participant received one of the following chemotherapy regimens at the discretion of treating physician:

FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil.

Protocol document: