This trial is active, not recruiting.

Conditions adult type ovarian granulosa cell tumor, ovarian gynandroblastoma, ovarian sertoli-leydig cell tumor, ovarian sex cord tumor with annular tubules, ovarian steroid cell tumor
Treatment paclitaxel
Phase phase 2
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date November 2000
End date July 2013
Trial size 31 participants
Trial identifier NCT00006227, CDR0000068149, GOG #0187, GOG-0187, NCI-2011-02054, U10CA027469, U10CA180868


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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 Anzatax
Given IV

Primary Outcomes

Frequency of complete clinical response, assessed using GOG RECIST criteria
time frame: Up to 5 years

Secondary Outcomes

Duration of progression-free survival
time frame: The period from study entry until disease progression, death or date of last contact, assessed up to 5 years
Overall survival
time frame: The observed length of life from entry into the study to death or the date of last contact, assessed up to 5 years

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
Principal investigator Linda Van Le
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.