Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

May 20, 2014 updated by: University of Southern California

Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine.
  • Determine the toxic effects of this regimen in these patients.
  • Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients.

OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel).

Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity.

All patients are followed until death.

PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent ovarian epithelial cancer

  • Platinum resistant disease defined as:

    • Progression during the most recent platinum-based chemotherapy OR
    • Relapse less than 6 months after platinum-based chemotherapy

  • Measurable or evaluable disease

    • Elevated CA-125 only allowed
    • Positive cytology only not eligible

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • AST less than 3 times ULN

Renal:

  • Creatinine no greater than 2 mg/dL

Neurologic:

  • No peripheral neuropathy greater than grade 2

Other:

  • No other serious medical illness or psychiatric conditions.

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent hematopoietic growth factors

Chemotherapy:

  • See Disease Characteristics
  • No prior gemcitabine
  • No prior paclitaxel administered weekly

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Recovered from acute toxic effects secondary to prior therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Agustin Garcia, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

June 1, 2002

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 23, 2003

First Posted (Estimate)

September 24, 2003

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066478 (5O-98-1)
  • LAC-USC-5O981
  • NCI-G98-1460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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