|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00108745 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial or peritoneal cancer or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: paclitaxel Drug: paclitaxel poliglumex Procedure: observation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy |
| Estimated Enrollment: | 1100 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.
|
Drug: paclitaxel poliglumex
Given IV
|
|
Arm II: Active Comparator
Patients receive paclitaxel IV over 3 hours on day 1.
|
Drug: paclitaxel
Given IV
|
|
Arm III: No Intervention
Patients receive no further anticancer treatment until evidence of disease progression.
|
Procedure: observation
No intervention
|
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms.
In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 1,110 patients (555 per treatment arm) will be accrued for this study within 8.5 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
The following histologic epithelial cell types are allowed:
The following histologic cell types are not allowed:
Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma
Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation
Must have completed at least 5, but no more that 8 courses of primary therapy comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based combination chemotherapy within the past 12 weeks AND have no symptoms of persistent cancer after completion of therapy
Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided the following criteria is met:
Must have undergone interval abdominal surgery after at least one but no more than 6 courses of standard chemotherapy
No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-UC-STUDY ucstudy@uci.edu | |
| Todd Cancer Institute at Long Beach Memorial Medical Center | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Krishnansu S. Tewari 562-933-0900 | |
| Providence Saint Joseph Medical Center - Burbank | Recruiting |
| Burbank, California, United States, 91505 | |
| Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente 818-847-3220 | |
| Rebecca and John Moores UCSD Cancer Center | Recruiting |
| La Jolla, California, United States, 92093-0658 | |
| Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Ilana Cass 310-423-3277 | |
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| United States, Colorado | |
| Boulder Community Hospital | Recruiting |
| Boulder, Colorado, United States, 80301-9019 | |
| Contact: Clinical Trials Office - Boulder Community Hospital 303-938-5253 | |
| CCOP - Colorado Cancer Research Program | Recruiting |
| Denver, Colorado, United States, 80224-2522 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Colorado Gynecologic Oncology Group, PC | Recruiting |
| Aurora, Colorado, United States, 80010 | |
| Contact: Susan Davidson, MD 303-315-7897 | |
| Exempla Lutheran Medical Center | Recruiting |
| Wheat Ridge, Colorado, United States, 80033 | |
| Contact: Clinical Trials Office - Exempla Lutheran Medical Center 303-403-3605 | |
| St. Joseph Hospital | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Penrose Cancer Center at Penrose Hospital | Recruiting |
| Colorado Springs, Colorado, United States, 80933 | |
| Contact: Clinical Trials Office - Penrose Cancer Center 719-776-5275 | |
| Porter Adventist Hospital | Recruiting |
| Denver, Colorado, United States, 80210 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Rose Medical Center | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| North Colorado Medical Center | Recruiting |
| Greeley, Colorado, United States, 80631 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Recruiting |
| Grand Junction, Colorado, United States, 81502 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| United States, Connecticut | |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Recruiting |
| Hartford, Connecticut, United States, 06102-5037 | |
| Contact: Clinical Trials Office - Helen and Harry Gray Cancer Center 860-545-5363 | |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06105 | |
| Contact: Allan R. Mayer, DO 860-714-7945 | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520-8028 | |
| Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
| 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 | |
| United States, District of Columbia | |
| Washington Cancer Institute at Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Clinical Trials Office - Washington Cancer Institute 202-877-8839 | |
| United States, Florida | |
| Bayfront Cancer Care Center at Bayfront Medical Center | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: James P. LaPolla, MD 727-821-9688 | |
| Florida Gynecologic Oncology - Fort Myers | Recruiting |
| Fort Myers, Florida, United States, 33905 | |
| Contact: Edward C. Grendys, MD 239-992-0077 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| M.D. Anderson Cancer Center at Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Jennifer Tseng, MD 321-841-1882 | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Recruiting |
| Fort Lauderdale, Florida, United States, 33308 | |
| Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi 954-776-3239 | |
| Morton Plant Hospital | Recruiting |
| Clearwater, Florida, United States, 33756 | |
| Contact: Hector A. Arango, MD 727-446-2111 | |
| Palm Beach Cancer Institute - West Palm Beach | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Daniel L. Spitz 561-366-4117 | |
| St. Vincent's Medical Center | Recruiting |
| Jacksonville, Florida, United States, 32204 | |
| Contact: Stephen L. Buckley, MD 904-389-3993 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Altanta, Georgia, United States, 30322 | |
| Contact: Joan Cain 404-778-5180 | |
| 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 | |
| John B. Amos Cancer Center | Recruiting |
| Columbus, Georgia, United States, 31904 | |
| Contact: Clinical Trials Office - John B. Amos Cancer Center 706-660-6404 | |
| Northeast Georgia Medical Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Contact: Andrew E. Green 770-535-3553 | |
| Central Georgia Gynecologic Oncology | Recruiting |
| Macon, Georgia, United States, 31201 | |
| Contact: Gary L. Eddy, MD 476-633-6090 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
| Hinsdale Hematology Oncology Associates | Recruiting |
| Hinsdale, Illinois, United States, 60521 | |
| Contact: Sudarshan K. Sharma, MD 630-856-6757 | |
| Regional Cancer Center at Memorial Medical Center | Recruiting |
| Springfield, Illinois, United States, 62781-0001 | |
| Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me 217-788-4233 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| 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 Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| United States, Indiana | |
| Gynecologic Oncology of Indiana | Recruiting |
| Indianapolis, Indiana, United States, 46237 | |
| Contact: David H. Moore 317-851-2555 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| 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, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160-7357 | |
| Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit 913-588-4709 | |
| United States, Kentucky | |
| Central Baptist Hospital | Recruiting |
| Lexington, Kentucky, United States, 40503-9985 | |
| Contact: Clinical Trials Office - Central Baptist Hospital 859-260-6425 | |
| James Graham Brown Cancer Center at University of Louisville | Recruiting |
| Louisville, Kentucky, United States, 40292 | |
| Contact: Mary E. Gordinier 502-562-4158 | |
| 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 | |
| Christus Schumpert Cancer Treatment Center | Recruiting |
| Shreveport, Louisiana, United States, 71101 | |
| Contact: Clinical Trials Office - Christus Schumpert Cancer Treatment C 318-681-4763 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Richard C. Kline, MD 504-842-4165 | |
| United States, Maryland | |
| Greater Baltimore Medical Center Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Clinical Trials Office - Greater Baltimore Medical Center Canc 443-849-3706 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| Contact: Wilson C. Mertens 413-794-9338 | |
| Tufts-NEMC Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Katie E. Wakeley 617-636-6100 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Marianne K. Lange, MD 616-977-6243 | |
| CCOP - Grand Rapids | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Martin J. Bury 616-391-1230 | |
| Gynecologic Oncology of West Michigan | Recruiting |
| Grand Rapids, Michigan, United States, 49546 | |
| Contact: Gordon O. Downey, MD 616-957-3398 | |
| Munson Medical Center | Recruiting |
| Traverse City, Michigan, United States, 49684 | |
| Contact: Marianne K. Lange, MD 616-977-6243 | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| William Beaumont Hospital - Royal Oak Campus | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak 248-551-7695 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| St. Luke's Hospital Cancer Care Center | Recruiting |
| Duluth, Minnesota, United States, 55805 | |
| Contact: Tanya L. Repka, MD, FACP 218-726-3081 | |
| United States, Mississippi | |
| Regional Cancer Center at Singing River Hospital | Recruiting |
| Pascagoula, Mississippi, United States, 39581 | |
| Contact: James E. Clarkson, MD 228-374-6296 | |
| St. Dominic Cancer Center | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Donald P. Seago 601-200-3070 | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: James T. Thigpen, MD 601-984-5590 | |
| United States, Missouri | |
| CCOP - Kansas City | Recruiting |
| Kansas City, Missouri, United States, 64131 | |
| Contact: Rakesh Gaur, MD 816-823-0555 | |
| Freeman Cancer Institute at Freeman Health System | Recruiting |
| Joplin, Missouri, United States, 64804 | |
| Contact: Anisa Hassan 417-347-3066 | |
| Hulston Cancer Center at Cox Medical Center South | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Robert L. Carolla 417-269-5257 | |
| Saint Louis University Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Clinical Trials Office - Saint Louis University Cancer Center 314-977-4440 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: David G. Mutch, MD 314-362-3181 | |
| St. John's Regional Health Center | Recruiting |
| Springfield, Missouri, United States, 65804 | |
| Contact: Robert L. Carolla 417-820-2000 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| Contact: Peter C. Morris, MD 402-354-5250 | |
| United States, Nevada | |
| Renown Institute for Cancer at Renown Regional Medical Center | Recruiting |
| Reno, Nevada, United States, 89502 | |
| Contact: Peter C. Lim 775-982-5050 | |
| Women's Cancer Center - Lake Mead | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| 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 | |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Howard M. Saul, DO 856-673-0015 | |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Recruiting |
| Marlton, New Jersey, United States, 08053 | |
| Contact: Clinical Trials Office - Fox Chase Virtua Health Cancer Progra 888-847-8823 | |
| Jersey Shore Cancer Center at Jersey Shore University Medical Center | Recruiting |
| Neptune, New Jersey, United States, 07754-0397 | |
| Contact: Henry E. Sprance, MD, PhD 732-776-4128 | |
| United States, New Mexico | |
| Southwest Gynecologic Oncology Associates, Incorporated | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Carolyn Y. Muller, MD 505-272-0185 | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| Long Island Jewish Medical Center | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Veena S. John 718-470-7000 | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Carol L. Brown, MD 212-639-7659 | |
| Monter Cancer Center of the North Shore-LIJ Health System | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Contact: Veena S. John 516-734-8959 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Monica P. Hayes 212-241-6500 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Stephanie V. Blank, MD 212-263-2668 | |
| Queens Cancer Center of Queens Hospital | Recruiting |
| Jamaica, New York, United States, 11432 | |
| Contact: Carol L. Brown, MD 212-639-7659 | |
| Stony Brook University Cancer Center | Recruiting |
| Stony Brook, New York, United States, 11794-9446 | |
| Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215 | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Ovadia Abulafia, MD 718-270-2152 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| Women's Cancer Care Associates | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Thomas P. Morrissey 518-458-1390 | |
| United States, North Carolina | |
| Alamance Cancer Center at Alamance Regional Medical Center | Recruiting |
| Burlington, North Carolina, United States, 27216 | |
| Contact: Janak K. Choksi, MD 336-538-7737 | |
| 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 | |
| Hope A Women's Cancer Center | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Timothy J. Vanderkwaak 828-670-8403 | |
| 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 | |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Recruiting |
| Greensboro, North Carolina, United States, 27403-1198 | |
| Contact: Clinical Trials Office - Moses Cone Regional Cancer Center at 336-621-8374 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| Contact: Walter H. Gajewski, MD 910-342-3000 | |
| 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 | |
| Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
| 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 | |
| David L. Rike Cancer Center at Miami Valley Hospital | Recruiting |
| Dayton, Ohio, United States, 45409 | |
| Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami 937-208-2079 | |
| Hillcrest Cancer Center at Hillcrest Hospital | Recruiting |
| Mayfield Heights, Ohio, United States, 44124 | |
| Contact: Peter G. Rose, MD 216-444-1712 | |
| McDowell Cancer Center at Akron General Medical Center | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Eric L. Jenison, MD 330-344-6041 | |
| 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, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Northwest Cancer Specialists at Rose Quarter Cancer Center | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: William E. Winter, III 503-228-6509 | |
| Williamette Gynecologic Oncology PC | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Paul R. Kucera, MD 503-561-5294 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
| Joan Karnell Cancer Center at Pennsylvania Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Patricia A. Ford, MD 215-829-6088 | |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Recruiting |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center 610-988-9323 | |
| 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 | |
| UPMC Cancer Center at Magee-Womens Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Clinical Trials Office - UPMC Cancer Center at Magee-Womens Ho 412-647-2811 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - CCOP - Upstate Carolina 800-486-5941 | |
| Hollings Cancer Center at Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 | |
| United States, South Dakota | |
| Black Hills Obstetrics & Gynecology LLP | Recruiting |
| Rapid City, South Dakota, United States, 57701 | |
| Contact: Helen L. Frederickson, MD 605-343-9224 | |
| United States, Tennessee | |
| Baptist Centers for Cancer Care | Recruiting |
| Memphis, Tennessee, United States, 38120 | |
| Contact: Clinical Trials Office - Baptist Centers for Cancer Care 901-226-3077 | |
| Chattanooga Gyn-Oncology | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Donald H. Chamberlain, MD, FACS, FACOG 423-698-2050 | |
| Chattanooga's Program in Women's Oncology | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Stephen E. DePasquale 423-266-3636 | |
| Hall and Martin, M.Ds., PC | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Contact: David A. Martin 865-971-4992 | |
| United States, Texas | |
| Harrington Cancer Center | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Clinical Trials Officec - Harrington Cancer Center 806-359-4673 ryokubaitis@harringtoncc.org | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Tri A. Dinh 713-441-1010 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555-0361 | |
| Contact: Clinical Trials Office - University of Texas Medical Branch 409-772-1950 | |
| United States, Utah | |
| LDS Hospital | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| Contact: Ross E. Morgan, MD 801-408-5757 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Virginia | |
| Carilion Gynecologic Oncology Associates | Recruiting |
| Roanoke, Virginia, United States, 24016 | |
| Contact: Natalie S. Gould 540-345-8574 | |
| Northern Virginia Pelvic Surgery Associates | Recruiting |
| Annandale, Virginia, United States, 22003 | |
| Contact: John C. Elkas 202-782-8513 | |
| University of Virginia Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Susan C. Modesitt 434-924-9333 | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| Virginia Oncology Associates - Hampton | Recruiting |
| Hampton, Virginia, United States, 23666 | |
| Contact: Alejandra M. Perez-Tamayo 757-827-9400 | |
| United States, Washington | |
| CCOP - Virginia Mason Research Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Thomas W. Malpass 206-341-0446 | |
| 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 | |
| United States, Wisconsin | |
| Aurora Women's Pavilion of West Allis Memorial Hospital | Recruiting |
| West Allis, Wisconsin, United States, 53227 | |
| Contact: Peter Johnson, MD 262-549-6662 | |
| Gundersen Lutheran Center for Cancer and Blood | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Medical Consultants, Limited | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Peter Johnson, MD 262-549-6662 | |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic 414-649-5717 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Vince Lombard Cancer Clinic at Aurora Health Center - Slinger | Recruiting |
| Slinger, Wisconsin, United States, 53086 | |
| Contact: Peter Johnson, MD 262-549-6662 | |
| Vince Lombardi Cancer Clinic - Sheboygan | Recruiting |
| Sheboygan, Wisconsin, United States, 53081 | |
| Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Sheboy 414-649-7200 | |
| St. Vincent Hospital Regional Cancer Center | Recruiting |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
| Study Chair: | Maurie Markman, MD | M.D. Anderson Cancer Center |
| Investigator: | Robert A. Burger, MD | Chao Family Comprehensive Cancer Center |
More Information
| Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
| Study ID Numbers: | CDR0000422427, GOG-0212 |
| Study First Received: | April 18, 2005 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00108745 History of Changes |
| Health Authority: | Unspecified |
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma |
ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma Brenner tumor ovarian undifferentiated adenocarcinoma fallopian tube cancer |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |