FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor: Abramson Cancer Center at Penn Medicine
Study ID: NCT01206530
Phase: PHASE1/PHASE2
Status: Completed

Conditions

Adenocarcinoma
Colon Cancer
Metastasis
Rectal Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine — DRUG
Dose:600 or 800 mg Route:PO daily Treatment Administration: Daily
Oxaliplatin — DRUG
Dose: 85mg/m2 Route: IV infusion over 2 hours Treatment Administration: Day 1
Leucovorin — DRUG
Dose: 400mg/m2 Route IV infusion over 2 hours Treatment Administration: Day 1
5-fluorouracil — DRUG
Dose: 400mg/m2 Route: IV bolus immediately following leucovorin Treatment Administration Day 1
5-fluorouracil — DRUG
Dose: 2,400mg/m2 Route: IV continuous infusion over 46 hours immediately following bolus injection. Treatment Administration: Days 1-2
Bevacizumab — DRUG

Study Details

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.