Dasatinib in Preventing Oxaliplatin-Induced Peripheral Neuropathy in Patients With Colorectal Cancer Receiving FOLFOX and Bevacizumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Colorectal Carcinoma
- Metastatic Colorectal Carcinoma
- Stage IV Colorectal Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) of dasatinib in combination with oxaliplatin and fluorouracil (5FU) (modified version 6 regimen of leucovorin, fluorouracil and oxaliplatin [mFOLFOX6]) with or without bevacizumab in patients with metastatic colorectal cancer, d...
PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) of dasatinib in combination with oxaliplatin and fluorouracil (5FU) (modified version 6 regimen of leucovorin, fluorouracil and oxaliplatin [mFOLFOX6]) with or without bevacizumab in patients with metastatic colorectal cancer, defined as the lowest intermittent dose of dasatinib that affects serum biomarkers of OCT2 without influencing the pharmacokinetic properties of oxaliplatin. II. To determine the toxicity profile (based on Chemotherapy-Induced Peripheral Neuropathy [CIPN]20 and Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0) of dasatinib in combination with oxaliplatin/5-FU/bevacizumab in patients with colorectal cancer. SECONDARY OBJECTIVES: I. To evaluate the influence of dasatinib on the pharmacokinetics of oxaliplatin and vice versa in these patients. OUTLINE: This is a dose-escalation study of dasatinib. Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin IV over 2 hours, fluorouracil slow IV push over 2-4 minutes followed by continuous infusion over 46 hours on days 1 and 15. Patients also receive dasatinib orally (PO) once daily (QD) on days 14, 15, and 28 of cycle 1 and day 1 of cycle 2. Patients may receive bevacizumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to cycle 3 day 1 in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT04164069
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Anne M Noonan, MBBChBAO, MSc Ohio State University Comprehensive Cancer Center