Ixabepilone to Treat Cervical Cancer
Condition: Cervical Carcinoma; Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Carcinoma, Non-SquamousType
MeSH terms: Carcinoma; Uterine Cervical Neoplasms; Carcinoma, Adenosquamous
Intervention: Ixempra (Ixabepilone (BMS-247550) )
Intervention description: Participants received Ixabepilone 6mg/m^2 for a total of 30mg/m^2 inpatient or outpatient intravenously over an hour on the first five days of each 21 day cycle.
Intervention MeSH terms: Epothilones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ixabepilone; BMS-247550; Ixempra; Cervical Cancer; Epothilone

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 class of drugs, which includes the drug
           Taxol. Taxol is widely used to treat a variety of cancers.

        -  Ixabepilone can work in cells that are resistant to Taxol.

      Objectives:

        -  To determine whether ixabepilone is effective for treating cervical cancer.

      Eligibility:

        -  Women 18 years of age or older with cervical cancer.

      Design:

        -  Patients receive ixabepilone intravenously (through a vein) over 60 minutes on the first
           5 days of each 21-day treatment cycle. Their dosage may be adjusted according to how
           their bodies respond to the drug.

        -  The number of cycles each woman receives depends on her response to the treatment.

        -  Patients have CT (computed tomography) scans and other tests before starting treatment
           and then every other treatment cycle to determine the response of the tumor to
           ixabepilone.

        -  Patients who can undergo a tumor biopsy (surgical removal of a sample of tumor tissue)
           are asked to have a biopsy done before starting treatment with ixabepilone and again on
           the fourth or fifth day of treatment. This procedure is optional.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Patients must fulfill all of the following criteria to be eligible for study admission:

          1. Age greater than or equal to 18 years.

          2. 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).

          3. Subjects with unresectable recurrent cervical cancer are eligible.

          4. Measurable disease that can be assessed using RECIST (Response Evaluation Criteria in
             Solid Tumors) criteria.

          5. Performance Status ECOG (Eastern Cooperative Oncology Group) 0-2.

          6. Life expectancy of 3 months or greater.

          7. 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.

          8. 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 .

          9. No serious intercurrent medical illness.

         10. The ability to understand and willingness to sign a written informed consent form, and
             to comply with the protocol.

         11. Prior therapy with cisplatin or carboplatin is required.

        EXCLUSION CRITERIA:

        Patients with any of the following will be excluded from study entry:

          1. Pregnant or nursing women are not eligible; neither are women of childbearing
             potential unless using effective contraception as determined by the patients
             physician.

          2. 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.

          3. Patients who are poor medical risk because of other non malignant systemic disease or
             active, uncontrolled infection.

          4. 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.

          5. Prior craniospinal radiation, or total body irradiation (TBI).

          6. Patients receiving other investigational drugs, or strong CYP3A3 inhibitors (see
             Section 3.6 for details) that cannot be discontinued or substituted.

          7. CTCAE (Common Terminology Criteria for Adverse Events) Grade 2 or greater motor or
             sensory neuropathy.

          8. Known prior severe hypersensitivity reactions to agents containing Cremophor
             (Trademark) EL.

          9. Women with localized disease who are potentially curable through surgical resection.