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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

September 11, 2000
October 24, 2012
November 2000
Not Provided
Frequency of complete clinical response [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00006227 on ClinicalTrials.gov Archive Site
  • Duration of progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
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Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy

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.

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.
Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
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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
Female
Not Provided
No
Not Provided
United States,   Japan
 
NCT00006227
CDR0000068149, GOG-0187
Not Provided
Philip J. DiSaia, Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Linda Van Le, MD UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2012

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