Paclitaxel in Treating Patients With Ovarian Stromal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2000

Last Updated Date

November 6, 2009

Start Date ^ICMJE

November 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Frequency of complete clinical response [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Frequency of complete clinical response

Change History

Complete list of historical versions of study NCT00006227 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Duration of progression-free survival
Overall survival

Descriptive Information

Brief Title ^ICMJE

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Official Title ^ICMJE

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

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer.

Detailed Description

OBJECTIVES:

Determine the clinical response to paclitaxel in patients with ovarian stromal cancer.
Determine toxicity of this drug in these patients.
Determine the value of inhibin for predicting response in these patients when treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment (yes vs no).

Patients receive paclitaxel 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.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed ovarian stromal cancer not amenable to surgery
- Granulosa cell tumor
- Granulosa cell theca cell tumor
- Sertoli-Leydig cell tumor (androblastoma)
- Gynandroblastoma
- Unclassified sex cord stromal tumor
- Sex cord tumor with annular tubules
- Steroid (lipid) cell tumor
Recurrent disease after no more than 1 prior chemotherapy regimen
Measurable disease
- At least 1 cm in diameter

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

GOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal

Renal:

Creatinine no greater than 2.0 mg/dL

Other:

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to study lesion

Surgery:

See Disease Characteristics

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Japan

Administrative Information

NCT ID ^ICMJE

NCT00006227

Responsible Party

Philip J. DiSaia, Gynecologic Oncology Group

Study ID Numbers ^ICMJE

CDR0000068149, GOG-0187

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Howard D. Homesley, MD

Gynecologic Oncology Network

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP