Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Granulosa Cell Tumor

Sex Cord-Gonadal Stromal Tumors

Leydig Cell Tumor

Sertoli-Leydig Cell Tumor

Neoplasms by Histologic Type

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Testicular Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Granulosa Cell Tumor of the Ovary

Sertoli-leydig Cell Tumors

Gynandroblastoma

Ovarian Sex Cord Tumor With Annular Tubules

Ovarian Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

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

Linda Van Le

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.

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.

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

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

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

Duration of progression free survival (median) (months)

Duration of overall survival (median) (months)

National Cancer Institute (NCI)

Gynecologic Oncology Group

Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.

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

Paclitaxel: Given IV

Treatment (Paclitaxel)

< 40

40-49

50-59

>= 60

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The protocol listed an overall study accrual range of 30 to 37, therefore the study achieved this accrual range (n=31). One patient had an indeterminate response for the primary outcome.

Spots Global Cancer Trial Database for adult type ovarian granulosa cell tumor