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PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer

NCT00059618 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-08-02

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.

Conditions

Interventions

DRUG

PS-341 (Bortezomib)

Starting dose 0.8 mg/m\^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.

DRUG

Carboplatin

AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Pedro T. Ramirez, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2007-04-30
Completion
2007-04-30

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 NCT00059618 on ClinicalTrials.gov