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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: dexamethasone Drug: gemcitabine hydrochloride Drug: paclitaxel Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 35 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer
Study Start Date : May 1998
Actual Primary Completion Date : June 2002
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003449

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Study Chair: Agustin Garcia, MD University of Southern California

Responsible Party: University of Southern California Identifier: NCT00003449     History of Changes
Other Study ID Numbers: CDR0000066478 (5O-98-1)
First Posted: September 24, 2003    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by University of Southern California:
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists