Clinical Research Details

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly-diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)

To evaluate the efficacy of pegfilgrastim as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature = 38.0°C (= 100.4°F) and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24-hour window of a temperature = 38.0°C or (= 100.4°F).

201999071509

800

Investigators will be expected to maintain a screening log of all potential study
candidates that includes limited information about the potential candidate (age, sex, race), date and outcome of the screening process (e.g., enrolled into study, reason for ineligibility, or refused to participate). This log will be completed and updated by telephoning an interactive voice response system (IVRS). Before any study-specific procedure, the appropriate written informed consent must be obtained.

Disease-related:
• Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum
• Locally-advanced or metastatic disease by radiographic evaluation (CT, MRI)
- Measurable disease as defined by revised RECIST Criteria (v1.1)
• Subject has not previously received chemotherapy for locally-advanced or metastatic CRC
- Subject may have received adjuvant therapy for primary colorectal cancer
provided that at least six months have elapsed from the time the adjuvant therapy was concluded and recurrent/metastatic disease was documented. It is
recommended that if progression occurred after six months but within 12 months following completion of adjuvant FOLFOX chemotherapy, subjects should receive FOLFIRI + bevacizumab as first-line chemotherapy, and vice versa. If > 12 months has elapsed before progression occurs, subjects may receive FOLFOX + bevacizumab or FOLFIRI + bevacizumab at physician’s discretion, regardless of what was received adjuvantly.
• ECOG performance status 0-2
Demographic:
• Age of 18 years or older
Laboratory:
Adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) at least 1.5 x 109/L
• Platelet count at least 100 x 109/L
• Bilirubin = 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN or AST and ALT = 5.0 x ULN if attributable to liver metastasis. Partial thromboplastin time (PTT) = 1.0 x ULN and international normalized ratio (INR) = 1.5, unless subject is on full dose anticoagulation therapy. Subjects on full dose anticoagulation are eligible if the following criteria are met:
- The subject has an in-range INR (usually between 2 and 3) on a stable dose of
oral anticoagulant or is on a stable dose of low molecular weight heparin.
- The subject has no active bleeding or pathological condition that carries high risk of bleeding (e.g., tumor involving major vessels or known varices).
• Creatinine = 1.5 times ULN
General:
• Written informed consent obtained
• Afebrile on day one of cycle one
• Must be able and willing to comply with study and/or follow-up procedures

The treatment period for this study will be two months. During the treatment period of the study, you will visit the clinic at least three times every two weeks. You will receive the specified treatment chosen by your doctor (either FOLFOX and bevacizumab or FOLFIRI and bevacizumab). Twenty-four hours after you finish your chemotherapy and bevacizumab, you will receive a shot of either pegfilgrastim or a placebo.

Deepak Malhotra, M.D.

(708) 327-3221