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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003449
Recruitment Status : Completed
First Posted : September 24, 2003
Last Update Posted : May 22, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

November 1, 1999
September 24, 2003
May 22, 2014
May 1998
June 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003449 on Archive Site
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Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
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.


  • 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.

Phase 2
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: dexamethasone
  • Drug: gemcitabine hydrochloride
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2004
June 2002   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status:

  • SWOG 0-2


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


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


  • Creatinine no greater than 2 mg/dL


  • No peripheral neuropathy greater than grade 2


  • No other serious medical illness or psychiatric conditions.


Biologic therapy:

  • No concurrent hematopoietic growth factors


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

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • Recovered from acute toxic effects secondary to prior therapy
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000066478 (5O-98-1)
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University of Southern California
University of Southern California
National Cancer Institute (NCI)
Study Chair: Agustin Garcia, MD University of Southern California
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP