Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Adult Type Ovarian Granulosa Cell Tumor; Ovarian Sex Cord Tumor With Annular Tubules; Ovarian Steroid Cell Tumor; Ovarian Gynandroblastoma; Ovarian Sertoli-Leydig Cell Tumor

Treatments: Drug: Paclitaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006227

U10CA027469 (U.S. NIH Grant/Contract)

U10CA180868 (U.S. NIH Grant/Contract)

GOG-0187

CDR0000068149

GOG #0187

NCI-2011-02054 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Treatment (paclitaxel)

Experimental group

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.

Treatment:

Drug: Paclitaxel