Paclitaxel in Treating Patients With Ovarian Stromal Cancer
This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006227
First received: September 11, 2000
Last updated: October 24, 2012
Last verified: October 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy |
Resource links provided by NLM:
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 |
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
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| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, California | |
| Todd Cancer Institute at Long Beach Memorial Medical Center | Recruiting |
| Long Beach, California, United States, 90806 | |
| Contact: Robert E. Bristow 562-933-0900 | |
| Palo Alto Medical Foundation | Recruiting |
| Mountain View, California, United States, 94040 | |
| Contact: Albert L. Pisani 650-934-7000 | |
| United States, Connecticut | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | Recruiting |
| New Britain, Connecticut, United States, 06050 | |
| Contact: Clinical Trials Office - George Bray Cancer Center 860-224-5660 | |
| United States, Delaware | |
| Tunnell Cancer Center at Beebe Medical Center | Recruiting |
| Lewes, Delaware, United States, 19958 | |
| Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |
| CCOP - Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-623-4450 | |
| United States, Georgia | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403-3089 | |
| Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568 | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Clinical Trials Office - Rush University Medical Center 312-942-5498 clinical_trials@rush.edu | |
| Gynecologic Oncology | Recruiting |
| Hinsdale, Illinois, United States, 60521 | |
| Contact: Sudarshan K. Sharma, MD 630-856-6757 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| Louisville Oncology at Norton Cancer Institute - Louisville | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Clinical Trials Office - Louisville Oncology 502-629-2500 | |
| United States, Maryland | |
| Union Hospital of Cecil County | Recruiting |
| Elkton MD, Maryland, United States, 21921 | |
| Contact: Mark E. Borowsky 410-398-4000 | |
| United States, Michigan | |
| Borgess Medical Center | Recruiting |
| Kalamazoo, Michigan, United States, 49001 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: James T. Thigpen, MD 601-984-5590 | |
| United States, Nevada | |
| Women's Cancer Center - La Canada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| Contact: Nick M. Spirtos, MD 408-866-3843 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |
| United States, New York | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Ovadia Abulafia, MD 718-270-2152 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Duke Cancer Institute | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Cancer Institute 888-275-3853 | |
| United States, Ohio | |
| Aultman Cancer Center at Aultman Hospital | Recruiting |
| Canton, Ohio, United States, 44710-1799 | |
| Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp 330-363-6891 | |
| Cleveland Clinic Cancer Center at Fairview Hospital | Recruiting |
| Cleveland, Ohio, United States, 44111 | |
| Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai 216-476-9362 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 Jamesline@osumc.edu | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| Hillcrest Cancer Center at Hillcrest Hospital | Recruiting |
| Mayfield Heights, Ohio, United States, 44124 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Pennsylvania | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402 | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Recruiting |
| Allentown, Pennsylvania, United States, 18105 | |
| Contact: Richard M. Boulay, MD 610-402-3650 | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a 717-531-3779 CTO@hmc.psu.edu | |
| Fox Chase Cancer Center CCOP Research Base | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center CCOP Research 215-728-2983 | |
| United States, South Carolina | |
| South Carolina Oncology Associates, PA | Recruiting |
| Columbia, South Carolina, United States, 29210 | |
| Contact: James A. Williams, MD 803-461-3000 | |
| United States, Virginia | |
| University of Virginia Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Susan C. Modesitt 434-924-9333 | |
| Japan | |
| Iwate Medical University Hospital | Recruiting |
| Morioka, Iwate, Japan, 020-8505 | |
| Contact: Toru Sugiyama 81-19-651-5111 | |
| Kagoshima City Hospital | Recruiting |
| Kagoshima City, Kagoshima, Japan, 892-8580 | |
| Contact: Masayuki Hatae, MD 81-99-224-2101 | |
| National Hospital Organization - Medical Center of Kure | Recruiting |
| Kure, Japan, 737 | |
| Contact: Kazuhiro Takehara 81-82-322-3111 | |
| Shikoku Cancer Center | Recruiting |
| Matsuyama, Japan, 791-0280 | |
| Contact: Takayoshi Nogawa 81-89-932-1111 | |
| Kinki University School of Medicine | Recruiting |
| Osaka, Osaka, Japan, 589 8511 | |
| Contact: Yoh Watanabe 81-723-66-0221 | |
| Hokkaido University Hospital | Recruiting |
| Sapporo, Japan, 060-8648 | |
| Contact: Noriaki Sakuragi 81-11-716-1161 ext. 6000 | |
| Tohoku University Graduate School of Medicine | Recruiting |
| Sendai, Japan, 980-8574 | |
| Contact: Nobuo Yaegashi 81-22-274-1111 | |
| Keio University School of Medicine | Recruiting |
| Shinjuku-ku, Japan, 160-8582 | |
| Contact: Nobuyuki Susumu, MD 81-3-3353-1211ext.62275 | |
| Tottori University Hospital | Recruiting |
| Tottori, Japan, 680-8550 | |
| Contact: Junzo Kigawa, MD, PhD 81-859-33-1111 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Study Chair: | Linda Van Le, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00006227 History of Changes |
| Other Study ID Numbers: | CDR0000068149, GOG-0187 |
| Study First Received: | September 11, 2000 |
| Last Updated: | October 24, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
ovarian stromal cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013