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.
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.
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
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There are 141 Locations for this study
Phoenix Arizona, 85013, United States
Concord California, 94520, United States
La Jolla California, 92093, United States
San Diego California, 92103, United States
Walnut Creek California, 94598, United States
Aurora Colorado, 80045, United States
Farmington Connecticut, 06030, United States
Hartford Connecticut, 06102, United States
Hartford Connecticut, 06105, United States
New Britain Connecticut, 06050, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Atlanta Georgia, 30309, United States
Savannah Georgia, 31405, United States
Boise Idaho, 83706, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Hinsdale Illinois, 60521, United States
New Lenox Illinois, 60451, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67905, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Lexington Kentucky, 40536, United States
Baton Rouge Louisiana, 70817, United States
Baltimore Maryland, 21204, United States
Elkton Maryland, 21921, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Jackson Mississippi, 39216, United States
Cape Girardeau Missouri, 63703, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Las Vegas Nevada, 89169, United States
Camden New Jersey, 08103, United States
Voorhees New Jersey, 08043, United States
Stony Brook New York, 11794, United States
Asheboro North Carolina, 27203, United States
Burlington North Carolina, 27215, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27403, United States
Hendersonville North Carolina, 28791, United States
Hendersonville North Carolina, 28791, United States
Kernersville North Carolina, 27284, United States
Mebane North Carolina, 27302, United States
Mount Airy North Carolina, 27030, United States
Reidsville North Carolina, 27320, United States
Thomasville North Carolina, 27360, United States
Wilkesboro North Carolina, 28659, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44304, United States
Akron Ohio, 44307, United States
Belpre Ohio, 45714, United States
Chillicothe Ohio, 45601, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45405, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Newark Ohio, 43055, United States
Portsmouth Ohio, 45662, United States
Springfield Ohio, 45505, United States
Toledo Ohio, 43614, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Abington Pennsylvania, 19001, United States
Bryn Mawr Pennsylvania, 19010, United States
Paoli Pennsylvania, 19301, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02905, United States
Rapid City South Dakota, 57701, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57105, United States
Bristol Tennessee, 37620, United States
Johnson City Tennessee, 37604, United States
Kingsport Tennessee, 37660, United States
Kingsport Tennessee, 37660, United States
Houston Texas, 77026, United States
Houston Texas, 77030, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Norton Virginia, 24273, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24016, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Seattle Washington, 98122, United States
Seattle Washington, 98133, United States
Seattle Washington, 98195, United States
Spokane Washington, 99202, United States
Walla Walla Washington, 99362, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Madison Wisconsin, 53792, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
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