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| 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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2000 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian stromal cancer not amenable to surgery
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| 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, 90801 | |
| Contact: Bradley J. Monk, MD 714-456-7974 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 | |
| Tunnell Cancer Center at Beebe Medical Center | Recruiting |
| Lewes, Delaware, United States, 19958 | |
| Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |
| 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 | |
| Hinsdale Hematology Oncology Associates | Recruiting |
| Hinsdale, Illinois, United States, 60521 | |
| Contact: Sudarshan K. Sharma, MD 630-856-6757 | |
| Joliet Oncology-Hematology Associates, Limited - West | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| Contact: Kendrith M. Rowland, MD 217-383-3019 | |
| 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 | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| 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 | |
| Louisville Oncology at Norton Cancer Institute - Louisville | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Clinical Trials Office - Louisville Oncology 502-629-2500 | |
| 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 | |
| United States, Louisiana | |
| Woman's Hospital | Recruiting |
| Baton Rouge, Louisiana, United States, 70815 | |
| Contact: Giles Fort, MD 225-358-1071 | |
| United States, Maryland | |
| Union Hospital Cancer Program at Union Hospital | 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, 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 Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| 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 | |
| Charles M. Barrett Cancer Center at University Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: William E. Richards 806-796-1317 | |
| 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 | |
| Hillcrest Cancer Center at Hillcrest Hospital | Recruiting |
| Mayfield Heights, Ohio, United States, 44124 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| United States, Oklahoma | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Pennsylvania | |
| 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 | |
| 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 Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| 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 | |
| United States, Texas | |
| Brooke Army Medical Center | Recruiting |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837 | |
| Wilford Hall Medical Center | Recruiting |
| Lackland AFB, Texas, United States, 78236 | |
| Contact: Charles A. Leath, III 210-292-7100 | |
| United States, Virginia | |
| University of Virginia Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Willie A. Andersen, MD 804-924-1851 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Benjamin E. Greer, MD 206-685-2463 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195-6043 | |
| Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 | |
| Japan | |
| Hokkaido University Hospital | Recruiting |
| Sapporo, Japan, 060-8648 | |
| Contact: Noriaki Sakuragi 81-11-716-1161 ext. 6000 | |
| Kagoshima City Hospital | Recruiting |
| Kagoshima City, Kagoshima, Japan, 892-8580 | |
| Contact: Masayuki Hatae, MD 81-99-224-2101 | |
| Kinki University School of Medicine | Recruiting |
| Osaka, Osaka, Japan, 589 8511 | |
| Contact: Yoh Watanabe 81-723-66-0221 | |
| 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: Masamichi Hiura, MD 81-89-999-1111 | |
| Tohoku University Graduate School of Medicine | Recruiting |
| Sendai, Japan, 980-8574 | |
| Contact: Tadao Takano, MD 81-22-717-7254 | |
| Tottori University Hospital | Recruiting |
| Tottori, Japan, 680-8550 | |
| Contact: Junzo Kigawa, MD, PhD 81-859-33-1111 | |
| Japan, Iwate | |
| Iwate Medical University Hospital | Recruiting |
| Morioka, Iwate, Japan, 020-8505 | |
| Contact: Toru Sugiyama 81-19-651-5111 | |
| Study Chair: | Howard D. Homesley, MD | Gynecologic Oncology Network |
More Information
| 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 |
|
ovarian stromal cancer |
|
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 |
