Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy

Summary

Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with fluorouracil and leucovorin calcium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and the best dose of giving panobinostat, fluorouracil, and leucovorin calcium together in treating patients with stage IV colorectal cancer who did not respond to previous fluorouracil-based chemotherapy.

Conditions

• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

DRUG

panobinostat

Given orally

DRUG

fluorouracil

Given IV

DRUG

leucovorin calcium

Given IV

PROCEDURE

biopsy

Correlative studies

GENETIC

reverse transcriptase-polymerase chain reaction

Correlative studies

GENETIC

western blotting

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

GENETIC

gene expression analysis

Correlative studies

GENETIC

RNA analysis

Correlative studies

GENETIC

polymorphism analysis

Correlative studies

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• University of Southern California

  lead OTHER

Principal Investigators

• Heinz-Josef Lenz · University of Southern California

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2014-12-31

Completion

2015-04-30

Countries

• United States

Study Locations