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Gynecologic Cancer

Temsirolimus + Carboplatin/Paclitaxel Stage III-IV Clear Cell Carcinoma of the Ovary (GOG-0268)
A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC#683864, IND#61010) in Combination with Carboplatin and Paclitaxel followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary
Status Conditions Phase Study ID
Closed Ovarian Cancer Phase II GOG 0268
NCT01196429
Summary

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temsirolimus, carboplatin, and paclitaxel together as first-line therapy works in treating patients with newly diagnosed stage III or stage IV clear cell ovarian cancer.


Investigator
Benjamin Greer, MD
Location    
PSOC Office 206-667-5152  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)

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
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.