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.
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
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.
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.
Adult Type Ovarian Granulosa Cell TumorOvarian GynandroblastomaOvarian Sertoli-Leydig Cell TumorOvarian Sex Cord Tumor With Annular TubulesOvarian Steroid Cell TumorPaclitaxelAlbumin-Bound Paclitaxel
You can join if…
Open to females
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
You CAN'T join if...
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
UCSF Medical Center-Mount Zion San Francisco, California, 94115, USA
Community Hospital of Los Gatos Los Gatos, California, 95032, USA
Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California, 94040, USA
Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach, California, 90806, USA
UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California, 90095, USA
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California, 92868, USA