A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
Condition: Endometrial Cancer
MeSH terms: Neoplasms; Endometrial Neoplasms; Neoplasms, Glandular and Epithelial; Uterine Neoplasms
Intervention: Carboplatin AUC; Abraxane
Intervention description: 100mg/m2
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uterus; gynecological; corpus uteri

Summary:

      The purpose of this study is to evaluate the safety of treatment with carboplatin and
      Abraxane in this patient population and determine the nature and degree of toxicities
      following treatment. The single stage open label Phase II feasibility study is designed to
      estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with
      no more than two dose level reductions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients must have high risk resected stage I disease (papillary serous
             histology, clear cell histology or carcinosarcoma), advanced stage (III or IV, all
             histologies) or recurrent endometrial cancer (all histologies). Patients do not need
             measurable disease and can enroll following surgery.

          -  Patients may not have received prior cytotoxic chemotherapy. However,
             nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed.
             Patients may have received prior radiation therapy (including whole pelvic or vaginal
             brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy
             must be discontinued at least 2 weeks prior to entry on this study.

          -  If patients underwent surgery, and chemotherapy is indicated after surgery either as
             adjuvant or to treat residual disease, study treatment should be initiated within 8
             weeks of surgery.

          -  In patients who have received prior radiation, at least 4 weeks should have elapsed
             since the completion of radiation therapy involving the whole pelvis or over 50% of
             the spine. If vaginal brachytherapy is planned with chemotherapy, it should be done
             before or after completion of chemotherapy treatment.

          -  Poorly differentiated histology, uterine papillary serous carcinoma, clear cell
             carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic
             component is epithelial (versus sarcomatous).

          -  Patients may have synchronous endometrial and ovarian cancer primaries.

          -  Patients must have a GOG performance status of 0, 1, or 2

          -  Patients must be at least 18 years of age.

          -  Patients must understand and willingly sign an approved informed consent, and
             authorization permitting release of personal health information.

          -  Patients must have adequate liver function: AST and ALT ≤ 2.5 X upper limit of normal
             (ULN), and bilirubin ≤ 1.5mg/dL.

          -  Patients must have adequate bone marrow function: platelets ≥ 100,000 cells/mm3
             (transfusion independent, defined as not receiving platelet transfusions within 7 days
             prior to laboratory sample), hemoglobin > 9.0g/dl and ANC ≥ 1,500 cells/mm3.

          -  Patients must have adequate renal function: creatinine < 1.5 mg/dL is recommended;
             however, institutional norms are acceptable.

          -  Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE).

        Exclusion Criteria:

          -  Other prior malignancies within 3 years, except non-melanoma skin cancers and
             synchronous ovarian primaries.

          -  Eligibility to a higher priority trial for first line or recurrent endometrial cancer
             (unless patient is unwilling to participate in such a trial).

          -  Patients with concomitant medical illness such as serious uncontrolled infection, or
             uncontrolled angina, which in the opinion of the treating physician, make the
             treatments prescribed on this study unreasonably hazardous for the patient.

          -  Patients who are pregnant or breastfeeding.

          -  Patients with third degree or complete heart block are not eligible unless a pacemaker
             is in place. Patients on medications, which alter cardiac conduction, such as
             digitalis, beta-blockers, or calcium channel blockers, or who have other conduction
             abnormalities or cardiac dysfunction could be entered at the discretion of the
             investigators.

          -  Patients with history of myocardial infarct within 6 months before enrollment, New
             York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious
             for congestive heart failure are not eligible unless a LVEF in the past 6 months is
             documented to be 50% or greater. Patients who have had a LVEF (performed for any
             reason) that is less than 50% in the past 6 months are ineligible.