Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), November 2009

First Received: September 11, 2000 Last Updated: November 21, 2009 History of Changes

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006227

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	45
Study Start Date:	November 2000

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006227

Show 50 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Howard D. Homesley, MD

Gynecologic Oncology Network

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers:	CDR0000068149, GOG-0187
Study First Received:	September 11, 2000
Last Updated:	November 21, 2009
ClinicalTrials.gov Identifier:	NCT00006227 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ovarian stromal cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009