Status:
TERMINATED
Ixabepilone to Treat Cervical Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Carcinoma
Cervical Adenocarcinoma
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief Summary
Background: * Ixabepilone is a member of the class of drugs called epothilones. These drugs interfere with the ability of cancer cells to replicate. * Epothilones are similar to taxanes, another clas...
Detailed Description
Background * Ixabepilone (Ixempra (Trademark), BMS-247550, NSC 710428) is a semi-synthetic analog of the natural product epothilone B. * The epothilones are a novel class of non-taxane microtubule-st...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must fulfill all of the following criteria to be eligible for study admission:
- Age greater than or equal to 18 years.
- Histologic or cytologic confirmation of cervical carcinoma, squamous or non-squamous. Within the non-squamous cohort is adenocarcinoma and adenosquamous as well as non-squamous (not otherwise specified).
- Subjects with unresectable recurrent cervical cancer are eligible.
- Measurable disease that can be assessed using RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
- Performance Status ECOG (Eastern Cooperative Oncology Group) 0-2.
- Life expectancy of 3 months or greater.
- Suitable candidate for receiving planned therapy as evidenced by screening laboratory assessments of hematologic, renal, hepatic, and metabolic functions: platelet count greater than or equal to 75,000/mm\^3, absolute granulocyte count (AGC) greater than or equal to 1,000/mm\^3, serum creatinine less than or equal to 1.6 or a measured creatinine clearance greater than or equal to 40 ml/min, SGPT (serum glutamic pyruvic transaminase) and SGOT (serum glutamic oxaloacetic transaminase) less than or equal to 2.5 times the NL (normal limit), and total bilirubin less than or equal to 1.5 times the NL (in patients with clinical evidence of Gilberts' disease, less than or equal to 3 times the NL).
- Note: A diagnosis of Gilbert s disease will be made in the presence of (1) unconjugated hyperbilirubinemia noted on several occasions; (2) normal results from CBC (complete blood count) count, reticulocyte count, and blood smear; (3) normal liver function test results; and (4) an absence of other disease processes that can explain the unconjugated hyperbilirubinemia.
- Greater than or equal to 4 weeks from prior radiation, intravenous chemotherapy or immunotherapy; greater than or equal to 6 weeks from prior nitrosourea; greater than or equal to 2 weeks from a prior phase 0 study .
- No serious intercurrent medical illness.
- The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol.
- Prior therapy with cisplatin or carboplatin is required.
- EXCLUSION CRITERIA:
- Patients with any of the following will be excluded from study entry:
- Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patients physician.
- Patients with a history of CNS (central nervous system) metastases, because symptoms/signs of progressive disease may be confused with drug-related toxicities, unless control has been achieved with either radiation or surgical resection at least three months prior to enrollment on study.
- Patients who are poor medical risk because of other non malignant systemic disease or active, uncontrolled infection.
- Human Immunodeficiency Virus (HIV) positive patients will be considered for eligibility, as long as they are not receiving antiretroviral drugs with strong CYP3A4 (cytochrome P450 3A4) inhibitory activity.
- Prior craniospinal radiation, or total body irradiation (TBI).
- Patients receiving other investigational drugs, or strong CYP3A3 inhibitors (see Section 3.6 for details) that cannot be discontinued or substituted.
- CTCAE (Common Terminology Criteria for Adverse Events) Grade 2 or greater motor or sensory neuropathy.
- Known prior severe hypersensitivity reactions to agents containing Cremophor (Trademark) EL.
- Women with localized disease who are potentially curable through surgical resection.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00924066
Start Date
November 1 2008
End Date
December 1 2013
Last Update
November 21 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892