Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma
About this trial
This is an interventional treatment trial for Fallopian Tube Clear Cell Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Patients with a histologic diagnosis of primary peritoneal carcinoma, or stage III or IV epithelial ovarian or fallopian tube carcinoma, with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; all patients must have had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified (NOS) Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of a platinum (IV or intraperitoneal [IP]) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal (no evidence of cancer) computed tomography (CT) scan of the abdomen/pelvis and normal cancer antigen 125 (CA-125) following this therapy Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV epithelial ovarian, primary peritoneal or, fallopian tube (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least one but no more than six cycles of standard chemotherapy; such surgery must meet the same criteria as for those undergoing up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease; also, patients must have received at least two cycles after interval abdominal surgery Absolute neutrophil count >= 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE version [v]3.0) grade 1 Platelet count >= 100,000/ul Creatinine =< 1.5 times institutional upper limit of normal (ULN), CTCAE v3.0 grade 1 Bilirubin =< 1.5 times ULN, (CTCAE v3.0 grade 1) Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times ULN (CTCAE v3.0 grade 1) Alkaline phosphatase =< 2.5 times ULN (CTCAE v3.0 grade 1) Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1 Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Patients must complete pre-entry assessments Exclusion Criteria: Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for their ovarian LMP tumor Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease Patients who have received investigational therapies, and/or biological therapies (i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded; however, biologics cannot be continued concurrent with the GOG-012 maintenance treatment (or observation); patients who have received prior chemotherapy for any other abdominal or pelvic tumor (except as noted above) are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than I-B Less than 3 mm invasion without vascular or lymphatic invasion No poorly differentiated subtypes, including papillary serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded Patients with acute hepatitis, or known chronic hepatitis Patients with an active infection that requires antibiotics Patients with ongoing gastrointestinal bleeding requiring blood product support Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up Patients with unstable angina or those who have had a myocardial infarction within the past six months; patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months Patients are excluded who have had prior therapy with CT-2103 Patients with active bleeding or an unexplained prothrombin time (PT) or partial thromboplastin time (PTT) > institutional upper limit normal (ULN) Patients who are pregnant or nursing are excluded; patients who may become pregnant must practice an effective method of birth control
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Tennessee Valley Gynecologic Oncology
- Saint Joseph's Hospital and Medical Center
- Mayo Clinic in Arizona
- Highlands Oncology Group PA - Fayetteville
- University of Arkansas for Medical Sciences
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- UC San Diego Moores Cancer Center
- Long Beach Memorial Medical Center-Todd Cancer Institute
- Kaiser Permanente Los Angeles Medical Center
- Cedars Sinai Medical Center
- UCLA / Jonsson Comprehensive Cancer Center
- Palo Alto Medical Foundation-Gynecologic Oncology
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- University of California San Diego
- UCSF Medical Center-Mount Zion
- University of Colorado Hospital
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Western States Cancer Research NCORP
- Rocky Mountain Gynecologic Oncology PC
- Poudre Valley Hospital
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Littleton Adventist Hospital
- McKee Medical Center
- Parker Adventist Hospital
- SCL Health Lutheran Medical Center
- University of Connecticut
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- Morton Plant Hospital
- Holy Cross Hospital
- Florida Gynecologic Oncology
- Southeast Gynecologic Oncology Associates
- Mayo Clinic in Florida
- AdventHealth Orlando
- Orlando Health Cancer Institute
- Women's Cancer Associates
- Sarasota Memorial Hospital
- Moffitt Cancer Center
- Emory University Hospital/Winship Cancer Institute
- John B Amos Cancer Center
- Northeast Georgia Medical Center-Gainesville
- Central Georgia Gynecologic Oncology
- Memorial Health University Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Northwestern University
- Rush University Medical Center
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Advocate Lutheran General Hospital
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Franciscan Health Indianapolis
- Saint Vincent Hospital and Health Care Center
- Community Howard Regional Health
- IU Health La Porte Hospital
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Cancer Center of Kansas - Newton
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- Norton Hospital Pavilion and Medical Campus
- The James Graham Brown Cancer Center at University of Louisville
- Woman's Hospital
- Tulane University Health Sciences Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- CHRISTUS Highland Medical Center
- University of Maryland/Greenebaum Cancer Center
- Greater Baltimore Medical Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Walter Reed National Military Medical Center
- Christiana Care - Union Hospital
- Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Baystate Medical Center
- UMass Memorial Medical Center - Memorial Division
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Hurley Medical Center
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Munson Medical Center
- Metro Health Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Abbott-Northwestern Hospital
- University of Minnesota/Masonic Cancer Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology PA-Woodbury
- Saint Dominic-Jackson Memorial Hospital
- University of Mississippi Medical Center
- Singing River Hospital
- University of Missouri - Ellis Fischel
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- SSM Health Saint Louis University Hospital
- Washington University School of Medicine
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Nebraska Methodist Hospital
- University of Nebraska Medical Center
- Women's Cancer Center of Nevada
- Center of Hope at Renown Medical Center
- Dartmouth Hitchcock Medical Center
- Cooper Hospital University Medical Center
- Morristown Medical Center
- Virtua Memorial
- Jersey Shore Medical Center
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Memorial Medical Center - Las Cruces
- Women's Cancer Care Associates LLC
- Island Gynecologic Oncology
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- New York Hospital Medical Center of Queens
- Queens Hospital Center
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- NYU Winthrop Hospital
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai Hospital
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Westchester Medical Center
- Hope Women's Cancer Centers-Asheville
- Cone Health Cancer Center at Alamance Regional
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Cone Health Cancer Center
- Gynecologic Oncology Network
- Rutherford Hospital
- New Hanover Regional Medical Center/Zimmer Cancer Center
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Aultman Health Foundation
- University of Cincinnati Cancer Center-UC Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Mount Carmel Health Center West
- Miami Valley Hospital
- Kettering Medical Center
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Providence Portland Medical Center
- Compass Oncology Rose Quarter
- Oregon Health and Science University
- Jefferson Abington Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- UPMC-Magee Womens Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Geisinger Medical Group
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Women and Infants Hospital
- AnMed Health Cancer Center
- Medical University of South Carolina
- Black Hills Obstetrics and Gynecology
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Chattanooga Gynecological Oncology
- Chattanooga's Program in Women's Oncology
- Knoxville Gynecologic Cancer Specialists PC
- Baptist Memorial Hospital and Cancer Center-Memphis
- Vanderbilt University/Ingram Cancer Center
- The Don and Sybil Harrington Cancer Center
- Dell Seton Medical Center at The University of Texas
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Lyndon Baines Johnson General Hospital
- Houston Methodist Hospital
- M D Anderson Cancer Center
- LDS Hospital
- University of Vermont Medical Center
- Northern Virginia Pelvic Surgery Associates
- University of Virginia Cancer Center
- Bon Secours Mary Immaculate Hospital
- Virginia Oncology Associates - Lake Wright
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Skagit Valley Hospital Regional Cancer Care Center
- Virginia Mason Medical Center
- Pacific Gynecology Specialists
- Fred Hutchinson Cancer Research Center
- Seattle Cancer Care Alliance
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Northwest
- University of Washington Medical Center - Montlake
- Cancer Care Northwest - Spokane South
- MultiCare Tacoma General Hospital
- Providence Saint Mary Regional Cancer Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Vince Lombardi Cancer Clinic-Sheboygan
- Vince Lombardi Cancer Clinic - Slinger
- ProHealth Waukesha Memorial Hospital
- Aurora West Allis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
Arm I (paclitaxel poliglumex)
Arm II (paclitaxel)
Arm III (observation)
Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive no further anticancer treatment until evidence of disease progression.