Paclitaxel in Treating Patients With Ovarian Stromal Cancer

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.

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