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Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003449
  Purpose

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 II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Gemcitabine hydrochloride Gemcitabine Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003449

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Norris Comprehensive Cancer Center
Investigators
Study Chair: Agustin Garcia, MD Norris Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066478, LAC-USC-5O981, NCI-G98-1460
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003449  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer

Study placed in the following topic categories:
Dexamethasone
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Gemcitabine
Dexamethasone acetate
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Hormonal
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Glucocorticoids
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Radiation-Sensitizing Agents
Autonomic Agents
Tubulin Modulators
Peripheral Nervous System Agents
Antineoplastic Agents, Phytogenic
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009