Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Phase 2

Completed

• Conditions: Adult Type Ovarian Granulosa Cell Tumor; Ovarian Gynandroblastoma; Ovarian Sex Cord Tumor With Annular Tubules; Ovarian Sertoli-Leydig Cell Tumor; Ovarian Steroid Cell Tumor
• Interventions: Drug: Paclitaxel

• Registration Number: NCT00006227
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2000-09-11
• Study Start: 2000-11-20
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2016-07-16
• Study Completion: 2016-07-16
• Status Verified: 2020-02
• Results First Submitted: 2020-02-18
• Results First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Results First Posted: 2020-03-05
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Probability of Complete Clinical Response	Up to 5 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (98)

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Banner Thunderbird Medical Center; 🇺🇸 Glendale, Arizona, United States

Banner-University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

Western Regional CCOP; 🇺🇸 Phoenix, Arizona, United States

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Long Beach Memorial Medical Center-Todd Cancer Institute; 🇺🇸 Long Beach, California, United States

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Community Hospital of Los Gatos; 🇺🇸 Los Gatos, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology; 🇺🇸 Mountain View, California, United States

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