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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California Identifier:
First received: November 1, 1999
Last updated: May 20, 2014
Last verified: May 2014

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 Intervention Phase
Ovarian Cancer Drug: dexamethasone Drug: gemcitabine hydrochloride Drug: paclitaxel Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by University of Southern California:

Enrollment: 35
Study Start Date: May 1998
Study Completion Date: February 2004
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: University of Southern California Identifier: NCT00003449     History of Changes
Other Study ID Numbers: CDR0000066478 (5O-98-1)
Study First Received: November 1, 1999
Last Updated: May 20, 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 processed this record on September 21, 2017