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FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer

NCT01206530 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Hydroxychloroquine

Dose:600 or 800 mg Route:PO daily Treatment Administration: Daily

DRUG

Oxaliplatin

Dose: 85mg/m2 Route: IV infusion over 2 hours Treatment Administration: Day 1

DRUG

Leucovorin

Dose: 400mg/m2 Route IV infusion over 2 hours Treatment Administration: Day 1

DRUG

5-fluorouracil

Dose: 400mg/m2 Route: IV bolus immediately following leucovorin Treatment Administration Day 1

DRUG

5-fluorouracil

Dose: 2,400mg/m2 Route: IV continuous infusion over 46 hours immediately following bolus injection. Treatment Administration: Days 1-2

DRUG

Bevacizumab

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Peter J. O'Dwyer, MD · Abramson Cancer Center at Penn Medicine

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206530 on ClinicalTrials.gov