Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006227
First received: September 11, 2000
Last updated: September 19, 2013
Last verified: September 2013

September 11, 2000
September 19, 2013
November 2000
March 2014   (final data collection date for primary outcome measure)
Frequency of complete clinical response, assessed using GOG RECIST criteria [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: The period from study entry until disease progression, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: The observed length of life from entry into the study to death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.

II. To evaluate the value of inhibin for predicting response.

OUTLINE:

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Stromal Cancer
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Experimental: Treatment (paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
Not Provided
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-2
  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Creatinine no greater than 2.0 mg/dL
  • Not pregnant
  • Negative pregnancy test
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Fertile patients must use effective contraception
  • No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer
  • No prior radiotherapy to study lesion
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Japan
 
NCT00006227
GOG-0187, NCI-2011-02054, CDR0000068149, GOG-0187, GOG-0187, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Linda Van Le Gynecologic Oncology Group
Gynecologic Oncology Group
September 2013

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