Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0
Condition: Gynecologic Malignancies
MeSH terms: Overweight
Intervention: Paclitaxel; Carboplatin
Intervention description: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles; area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chemotherapy dosing; Body surface area; BSA; paclitaxel; carboplatin; dose dense

Summary:

      The purpose of this study is to evaluate the side effects and effectiveness of giving
      standard paclitaxel chemotherapy in doses based on actual body surface area in combination
      with standard dosed carboplatin chemotherapy for overweight women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a histologically confirmed or presumed diagnosis of gynecologic
             malignancy for whom chemotherapy with paclitaxel and carboplatin is planned.

          -  Body Surface area >2.0

          -  Patients must have adequate:

               -  Renal function: Creatinine <1.5 x Institutional upper limits of normal (ULN)

               -  Bone marrow function:

                    -  Absolute neutrophil count (ANC) ≥ 1,500/mcl. This ANC cannot have been
                       induced or supported by granulocyte colony stimulating factors.

                    -  Platelets ≥ 100,000/mcl.

               -  Hepatic function:

                    -  Bilirubin ≤ 1.5 x ULN.

                    -  Aspartate aminotransferase (AST) (SGOT) ≤ 2.5 x ULN.

                    -  Alkaline phosphatase ≤ to 2.5 x ULN.

               -  Neurologic function:

                    -  Neuropathy (sensory and motor) ≤ CTCAE Grade 1.

          -  Patients must have a Eastern Cooperative Oncology Group (ECOG) Performance Status of
             0, 1, or 2.

          -  Patients must be entered within 12 weeks of diagnosis.

          -  Subjects must have the ability to understand and the willingness to sign a written
             informed consent document.

        Exclusion Criteria:

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis. 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.

          -  Patients with acute hepatitis or active infection that requires parenteral
             antibiotics.

          -  Patients with clinically significant cardiovascular disease. This includes:

               -  Myocardial infarction or unstable angina < 6 months prior to registration.

               -  New York Heart Association (NYHA) Grade II or greater congestive heart failure

               -  Serious cardiac arrhythmia requiring medication. This does not include
                  asymptomatic, atrial fibrillation with controlled ventricular rate.

          -  Patients who are pregnant or nursing.

          -  Patients with medical history or conditions not otherwise previously specified which
             in the opinion of the investigator should exclude participation in this study.

          -  Patients with known allergy to cremophor or polysorbate 80.