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Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006227
First received: September 11, 2000
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer.


Condition Intervention Phase
Ovarian Cancer
 Drug: paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

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

Primary Outcome Measures:
  • Frequency of complete clinical response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: November 2000
Detailed Description:

OBJECTIVES:

  • Determine the clinical response to paclitaxel in patients with ovarian stromal cancer.
  • Determine toxicity of this drug in these patients.
  • Determine the value of inhibin for predicting response in these patients when treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment (yes vs no).

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian stromal cancer not amenable to surgery

    • Granulosa cell tumor
    • Granulosa cell theca cell tumor
    • Sertoli-Leydig cell tumor (androblastoma)
    • Gynandroblastoma
    • Unclassified sex cord stromal tumor
    • Sex cord tumor with annular tubules
    • Steroid (lipid) cell tumor
  • Recurrent disease after no more than 1 prior chemotherapy regimen

  • Measurable disease

    • At least 1 cm in diameter

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to study lesion

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006227

  Show 46 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Linda Van Le, MD UNC Lineberger Comprehensive Cancer Center
  More Information

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

No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006227     History of Changes
Other Study ID Numbers: CDR0000068149, GOG-0187
Study First Received: September 11, 2000
Last Updated: October 24, 2012
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013