Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Brief Title

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Official Title

Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Probability of Complete Clinical Response

Secondary Outcome

 Progression-free Survival

Condition

Adult Type Ovarian Granulosa Cell Tumor

Intervention

Paclitaxel

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

November 20, 2000

Completion Date

July 16, 2016

Primary Completion Date

July 16, 2016

Eligibility Criteria

        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
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Linda Van Le, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT00006227

Organization ID

GOG-0187

Secondary IDs

NCI-2011-02054

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Linda Van Le, Principal Investigator, NRG Oncology


Verification Date

February 2020