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Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006227
First received: September 11, 2000
Last updated: March 16, 2016
Last verified: March 2016

September 11, 2000
March 16, 2016
November 2000
July 2013   (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 ]
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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.

PRIMARY 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 intravenously (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: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Type Ovarian Granulosa Cell Tumor
  • Ovarian Gynandroblastoma
  • Ovarian Sertoli-Leydig Cell Tumor
  • Ovarian Sex Cord Tumor With Annular Tubules
  • Ovarian Steroid Cell Tumor
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
31
Not Provided
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules)
  • Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen
  • Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • White blood count equal to or greater than 3000/mcl
  • Granulocyte count equal to or greater than 1500/mcl
  • Platelet count equal to or greater than 100,000/mcl
  • Creatinine equal to or less than 2.0 mg%
  • Bilirubin less than or equal to 1.5 times normal
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal
  • Patients with a GOG performance grade of 0, 1 or 2
  • Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
  • Patients who have met the pre-entry requirements as specified
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

  • Patients with GOG performance grade of 3 or 4
  • Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
  • Patients having received more than one prior chemotherapy regimen
  • Patients amenable to cure by surgery
  • Patients with prior radiation except for those whose recurrent disease is outside the radiation port
Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States,   Japan
 
NCT00006227
GOG-0187, NCI-2011-02054, GOG #0187, CDR0000068149, GOG-0187, GOG-0187, U10CA180868, U10CA027469
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Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Linda Van Le NRG Oncology
Gynecologic Oncology Group
March 2016

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