SCCA Gynecologic Cancer Clinical Trials

DISEASE CHARACTERISTICS:

• Diagnosis of stage III or IV clear cell ovarian cancer

  • Primary tumors must be ≥ 50% clear cell histomorphology* NOTE: *Appropriate tissue sections to confirm stage and histologic classification of cell type must be sent to GOG for central pathology review.
• No primary peritoneal or fallopian tube carcinoma
• Negative for the expression of WT-1 antigen and estrogen receptor (ER) antigen by IHC** NOTE: **Immunohistochemical stained slide for ER and WT-1 antigen must be submitted to GOG for pathology review.

• Newly diagnosed disease

  • Undergone initial surgery for the combined purpose of diagnosis, staging, and cytoreduction within the past 2-12 weeks

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Total bilirubin normal
• AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN for patients with liver metastases)
• Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN for patients with liver metastases)
• Creatinine ≤ 1.5 times ULN
• Cholesterol ≤ 350 mg/dL (fasting)
• Triglycerides ≤ 400 mg/dL (fasting)
• Albumin ≥ 3.0 mg/dL
• PT such that INR is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus)
• PTT < 1.2 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• Neurologic function (sensory and motor) ≤ CTCAE grade 1
• No severely impaired lung function, defined as a DLCO ≤ 50% of the normal predicted value and/or oxygen saturation ≤ 88% at rest on room air
• No baseline requirement for oxygen

• None of the following:

  • NYHA class III-IV symptomatic congestive heart failure
  • Unstable angina pectoris
  • Myocardial infarction within the past 6 months
  • Serious uncontrolled cardiac arrhythmia
  • Any other clinically significant disease
• No poorly controlled diabetes
• No active infection requiring antibiotics (except for uncomplicated urinary tract infection)
• No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
• No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
• No other serious concurrent illness that, in the opinion of the treating physician, will place the patient at unreasonable risk from study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior cancer treatment that contraindicates study therapy
• No prior treatment with a mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin

• No prior radiotherapy to any portion of the abdominal cavity or the pelvis

  • Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed provided that it was completed ≥ 5 years before registration and the patient remains free of recurrent or metastatic disease
• No prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant chemotherapy for the clear cell ovarian cancer
• No concurrent maintenance corticosteroids except for short-term (< 5 days) use
• No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital), any other CYP3A4 inducer (e.g., rifampin, St. John wort), or strong CYP3A4 inhibitors
• No other concurrent investigational agents
• No concurrent sunitinib
• No concurrent live vaccines