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Azacitidine and Valproic Acid Plus Carboplatin in Patients With Ovarian Cancer

NCT00529022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-02-20

No results posted yet for this study

Summary

The goal of this clinical research study is to find out if giving azacitidine with valproic acid plus carboplatin can help control advanced cancer. The safety of this treatment will be studied as well. Researchers will also collect some extra blood samples for molecular marker studies (studies that may help researchers predict how participants respond to the combined therapy).

There were to be two phases of this study: a Phase 1 portion to find acceptable doses of the study drug combination, and a Phase 2 portion to study the response rates to the treatment schedule. The study did not proceed to the Phase 2 portion.

Conditions

Interventions

DRUG

Azacitidine

75 mg/m\^2 Subcutaneous Injection or by vein Daily for 5 Days.

DRUG

Valproic Acid

40 mg/kg by mouth Daily for 7 days.

DRUG

Carboplatin

AUC 2 by vein on Days 3 and 10 over 60 Minutes.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gerald Falchook, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2012-10-31
Completion
2012-10-31

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 NCT00529022 on ClinicalTrials.gov