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Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: April 18, 2005   Last Updated: November 24, 2009   History of Changes
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peripheral neuropathy by Gynecologic Oncology Group (GOG) NTX4 at 6 months after study enrollment [ Designated as safety issue: No ]
  • General quality of life by Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index (FACT-O-TOI) at 6 months after study enrollment [ Designated as safety issue: No ]
  • Exploratory assessment of several tissue and serum angiogenic markers for prognosis by immunohistochemistry and antibody array prior to treatment in courses 1 and 2 [ Designated as safety issue: No ]
  • Exploratory time-dependent assessment of quality of life and peripheral neuropathy by FACT-O-TOI and GOG-NTX4 monthly during year 1 and then every 3 months for 2 years [ Designated as safety issue: No ]

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

Detailed Description:

OBJECTIVES:

Primary

  • Compare overall survival of patients with stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer in clinical complete response after prior primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until documented disease progression.

Secondary

  • Compare progression-free survival of patients treated with these drugs.
  • Compare the toxicity profile of these drugs, particularly peripheral neuropathy, in these patients.
  • Compare the quality of life of patients treated with these drugs.

Tertiary

  • Correlate angiogenic marker expression with overall or progression-free survival of patients treated with these drugs.

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.

  • Arm I: Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.
  • Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
  • Arm III: Patients receive no further anticancer treatment until evidence of disease progression.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer
  • The following histologic epithelial cell types are allowed:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
  • The following histologic cell types are not allowed:

    • Germ cell tumor
    • Sex cord-stromal tumor
    • Carcinosarcoma
    • Mixed müllerian tumor or carcinosarcoma
    • Metastatic carcinoma from other sites to the ovary
    • Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma

      • Patients with a prior diagnosis of LMP tumor that was surgically resected and who subsequently developed invasive adenocarcinoma are eligible provided patient did not receive prior chemotherapy for the ovarian LMP tumor
  • Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation

    • Optimal (≤ 1 cm) residual disease OR suboptimal residual disease after initial surgery
  • 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

    • CT scan of the abdomen and/or pelvis normal
    • CA 125 normal
  • 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

      • Surgery must meet the same criteria as the up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease
      • Patients must have received at least 2 courses after interval abdominal surgery
  • No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met:

    • Stage ≤ IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No active bleeding

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • PT or PTT normal
  • No acute or chronic hepatitis

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided the disease has remained stable within the past 6 months
  • No unstable angina
  • No myocardial infarction within the past 6 months

Other

  • No neuropathy (sensory and motor) ≥ grade 2
  • No active infection requiring antibiotics
  • No ongoing gastrointestinal bleeding requiring blood product support
  • No circumstance that would preclude study participation
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or pelvic tumor

Chemotherapy

  • See Disease Characteristics
  • No prior polyglutamate paclitaxel
  • No prior chemotherapy for any other abdominal or pelvic tumor
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND no recurrent or metastatic disease

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND no recurrent or metastatic disease

Surgery

  • See Disease Characteristics

Other

  • No prior investigational therapy for any other abdominal or pelvic tumor
  • No prior anticancer therapy that would preclude study therapy
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108745

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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        
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Maurie Markman, MD M.D. Anderson Cancer Center
Investigator: Robert A. Burger, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009