Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (paclitaxel)<br>Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. | Drug: Paclitaxel<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of Complete Clinical Response | The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Duration of progression free survival (median) (months) | The period from study entry until disease progression, death or date of last contact | 
| Overall Survival | Duration of overall survival (median) (months) | The observed length of life from entry into the study to death or the date of last contact |