G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer
- Sponsor
- Federation Francophone de Cancerologie Digestive
- Study ID
- NCT00541125
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICAL
- filgrastim — BIOLOGICAL
- fluorouracil — DRUG
- irinotecan hydrochloride — DRUG
- leucovorin calcium — DRUG
Study Details
RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer. PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.
Key Dates
- Start date
- Nov 30, 2007
- Status verified
- May 2016
- Primary completion
- Sep 30, 2013
- Completion
- Dec 31, 2013
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Other: FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaireFOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
Primary Outcome Measure
Rate of neutropenia grade 4 or fever [ Time Frame: 2013 ]
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