Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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 must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
- 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's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
- All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
- Patients must have a GOG performance status of 0, 1, or 2
- Patients must have baseline lactate dehydrogenase (LDH) levels =< 0.8 x upper limit of normal (ULN)
Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
- Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
Prior therapy
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
- Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens; (Note: optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy; non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a phase II trial)
- Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
- Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
- Patients must be considered platinum resistant or refractory according to standard GOG criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, or have progressed during platinum-based therapy
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
- Bilirubin less than or equal to 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients must meet pre-entry requirements
- Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
Cautions and prohibited medications/treatments
- Since elesclomol is a substrate for cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9), cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6), cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) and an inducer of CYP3A4, cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome P450 family 2, subfamily A, polypeptide 6 (CYP2A6), and cytochrome P450 family 2, subfamily E, polypeptide 1 (CY2E1), it is recommended that the following be used with caution: sensitive substrates of CYP3A4, CYP1A2, and CY2E1, and strong inhibitors and inducers of CYP2C9, CYP2D6, CYP2C19, and CYP3A4
Exclusion Criteria:
- Patients who have had prior therapy with elesclomol or prior second-line cytotoxic chemotherapy
- Patients who have received radiation to more than 25% of marrow-bearing areas
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients who are pregnant or breastfeeding
Sites / Locations
- Saint Joseph's Hospital and Medical Center
- John Muir Medical Center-Concord Campus
- UC San Diego Moores Cancer Center
- University of California San Diego
- John Muir Medical Center-Walnut Creek
- University of Colorado Hospital
- University of Connecticut
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Piedmont Hospital
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- UC Comprehensive Cancer Center at Silver Cross
- Indiana University/Melvin and Bren Simon Cancer Center
- Saint Vincent Hospital and Health Care Center
- McFarland Clinic PC - Ames
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- 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
- Cancer Center of Kansas-Kingman
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- 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
- University of Kentucky/Markey Cancer Center
- Woman's Hospital
- Greater Baltimore Medical Center
- Christiana Care - Union Hospital
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Beaumont Hospital - Dearborn
- Ascension Saint John Hospital
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Ascension Saint Mary's Hospital
- Saint John Macomb-Oakland Hospital
- University of Mississippi Medical Center
- Saint Francis Medical Center
- Washington University School of Medicine
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Women's Cancer Center of Nevada
- Cooper Hospital University Medical Center
- MD Anderson Cancer Center at Cooper-Voorhees
- Stony Brook University Medical Center
- Randolph Hospital
- Cone Health Cancer Center at Alamance Regional
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Novant Health Cancer Institute - Kernersville
- Cone Heath Cancer Center at Mebane
- Novant Health Cancer Institute - Mount Airy
- Annie Penn Memorial Hospital
- Novant Health Cancer Institute - Thomasville
- Novant Health Cancer Institute - Wilkesboro
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Winston-Salem Health Care
- Wake Forest University Health Sciences
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Strecker Cancer Center-Belpre
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Marietta Memorial Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- University of Toledo
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Jefferson Abington Hospital
- Bryn Mawr Hospital
- Paoli Memorial Hospital
- Lankenau Medical Center
- Women and Infants Hospital
- Black Hills Obstetrics and Gynecology
- Rapid City Regional Hospital
- Avera Cancer Institute
- Wellmont Bristol Regional Medical Center
- Wellmont Medical Associates Oncology and Hematology-Johnson City
- Regional Cancer Center at Indian Path Community Hospital
- Wellmont Holston Valley Hospital and Medical Center
- Lyndon Baines Johnson General Hospital
- M D Anderson Cancer Center
- University of Vermont Medical Center
- University of Virginia Cancer Center
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- 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
- Providence Saint Mary Regional Cancer Center
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (paclitaxel, elesclomol sodium)
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.