drugset / Trial / NCT01206530
FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer
Treatment
Summary
In this Phase I/II clinical trial, the investigators seek to pilot the addition of hydroxychloroquine (HCQ) to the standard front-line therapy of colorectal cancer, FOLFOX/bevacizumab. In toxicity terms, the investigators previous studies lead them to believe that a full dose (800mg) of HCQ will be well-tolerated in this setting. By starting at 600 mg, the investigators will ensure that the full dose is approached with an eye to safety, and if needed, the investigators will use the lower dose. Both doses achieve autophagy inhibition in our current studies.
Timeline
- Start
- 2010-09
- Primary completion
- 2017-09
- Completion
- 2017-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 600 mg | Oral |
| Subject | Hydroxychloroquine | Small molecule | 800 mg | Oral |
| Background | Bevacizumab | Monoclonal antibody | — | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |