Ovarian Cancer Clinical Trial

Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Summary

This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses.

II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel.

OUTLINE:

Patients receive paclitaxel intravenously (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.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00888615

Recruitment Status:

Completed

Sponsor:

GOG Foundation

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There are 141 Locations for this study

See Locations Near You

Saint Joseph's Hospital and Medical Center
Phoenix Arizona, 85013, United States
John Muir Medical Center-Concord Campus
Concord California, 94520, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
University of California San Diego
San Diego California, 92103, United States
John Muir Medical Center-Walnut Creek
Walnut Creek California, 94598, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
University of Connecticut
Farmington Connecticut, 06030, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain Connecticut, 06050, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Piedmont Hospital
Atlanta Georgia, 30309, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale Illinois, 60521, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox Illinois, 60451, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis Indiana, 46260, United States
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Woman's Hospital
Baton Rouge Louisiana, 70817, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Christiana Care - Union Hospital
Elkton Maryland, 21921, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Allegiance Health
Jackson Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Borgess Medical Center
Kalamazoo Michigan, 49048, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Lake Huron Medical Center
Port Huron Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees New Jersey, 08043, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
Cone Health Cancer Center at Alamance Regional
Burlington North Carolina, 27215, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro North Carolina, 27403, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville North Carolina, 28791, United States
Margaret R Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
Novant Health Cancer Institute - Kernersville
Kernersville North Carolina, 27284, United States
Cone Heath Cancer Center at Mebane
Mebane North Carolina, 27302, United States
Novant Health Cancer Institute - Mount Airy
Mount Airy North Carolina, 27030, United States
Annie Penn Memorial Hospital
Reidsville North Carolina, 27320, United States
Novant Health Cancer Institute - Thomasville
Thomasville North Carolina, 27360, United States
Novant Health Cancer Institute - Wilkesboro
Wilkesboro North Carolina, 28659, United States
Novant Health Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Novant Health Oncology Specialists
Winston-Salem North Carolina, 27103, United States
Winston-Salem Health Care
Winston-Salem North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Summa Health System - Akron Campus
Akron Ohio, 44304, United States
Cleveland Clinic Akron General
Akron Ohio, 44307, United States
Strecker Cancer Center-Belpre
Belpre Ohio, 45714, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Columbus Oncology and Hematology Associates Inc
Columbus Ohio, 43214, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus Ohio, 43215, United States
Grant Medical Center
Columbus Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus Ohio, 43219, United States
Mount Carmel Health Center West
Columbus Ohio, 43222, United States
Doctors Hospital
Columbus Ohio, 43228, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Delaware Health Center-Grady Cancer Center
Delaware Ohio, 43015, United States
Delaware Radiation Oncology
Delaware Ohio, 43015, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Lancaster Radiation Oncology
Lancaster Ohio, 43130, United States
Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Hillcrest Hospital Cancer Center
Mayfield Heights Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor Ohio, 44060, United States
Knox Community Hospital
Mount Vernon Ohio, 43050, United States
Licking Memorial Hospital
Newark Ohio, 43055, United States
Newark Radiation Oncology
Newark Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth Ohio, 45662, United States
Springfield Regional Medical Center
Springfield Ohio, 45505, United States
University of Toledo
Toledo Ohio, 43614, United States
Saint Ann's Hospital
Westerville Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Jefferson Abington Hospital
Abington Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States
Black Hills Obstetrics and Gynecology
Rapid City South Dakota, 57701, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Wellmont Bristol Regional Medical Center
Bristol Tennessee, 37620, United States
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City Tennessee, 37604, United States
Regional Cancer Center at Indian Path Community Hospital
Kingsport Tennessee, 37660, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport Tennessee, 37660, United States
Lyndon Baines Johnson General Hospital
Houston Texas, 77026, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
University of Vermont Medical Center
Burlington Vermont, 05401, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Southwest VA Regional Cancer Center
Norton Virginia, 24273, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke Virginia, 24016, United States
Pacific Gynecology Specialists
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
University of Washington Medical Center - Northwest
Seattle Washington, 98133, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Providence Saint Mary Regional Cancer Center
Walla Walla Washington, 99362, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay Wisconsin, 54303, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc Wisconsin, 54221, United States
Bay Area Medical Center
Marinette Wisconsin, 54143, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00888615

Recruitment Status:

Completed

Sponsor:


GOG Foundation

How clear is this clinincal trial information?

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