At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed colorectal adenocarcinoma
- ✓Locally-advanced or metastatic disease by radiographic evaluation
- ✓Measurable disease
- ✓No prior chemotherapy for locally-advanced or metastatic colorectal cancer (prior adjuvant allowed if ≥6 months elapsed and recurrent/metastatic disease documented)
- ✕Known brain metastases
- ✕Other primary malignancy within ≤5 years prior to randomization (except non-melanoma skin cancer, cervical carcinoma in situ, prostatic intraepithelial neoplasia without prostate cancer)
- ✕Major surgical procedure within 28 days prior to day 1 of cycle 1 or anticipated need during 4-cycle treatment period
- ✕Fine needle aspirations or core biopsies within 7 days prior to day 1 of cycle 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
In Brief
A Phase 3 clinical trial evaluating Pegfilgrastim, Placebo, and 2 other interventions for Cancer and 7 related conditions. Completed, enrolled 847 participants across 154 sites in 17 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product.
Administered as a single subcutaneous injection using a pre-filled syringe.
5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle.
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.