Research and Clinical Trials

Brief Description  
The main purpose of this study is to determine the effectiveness of the investigational drug temsirolimus in combination with paclitaxel and carboplatin in treating advanced stage of clear cell cancer of the ovary. Patients receive 6 cycles of paclitaxel and carboplatin with temsirolimus followed by 11 additional cycles of temsirolimus for maintenance treatment.
Who may be Eligible  

Eligibility criteria:

  1. stage 3 or 4 clear cell ovarian cancer;
  2. must begin study between 2 and 12 weeks after initial surgery;
  3. 18 years older or older;
  4. free of active infection requiring antibiotics (with exception on uncomplicated urinary tract infection);
  5. adequate blood counts;
  6. cholesterol less than or equal to 350 (fasting) and trigylcerides less than or equal to 400 (fasting);
  7. blood clotting time within normal range if not on warfarin or on stable dose of warfarin and blood clotting time within therapeutic range;
  8. peripheral neuropathy not greater than grade 1

Ineligible patients:

  1. history of previous invasive cancers within the past 5 years;
  2. history of radiation therapy to any portion of abdomen;
  3. previous chemotherapy for any abdominal or pelvic tumor;
  4. primary peritoneal and fallopian tube cancer;
  5. severely impaired lung function;
  6. congestive heart failure, unstable angina, heart attack within past 6 months, serious uncontrolled heart arrhythmias;
  7. active bleeding or bleeding disorders;
  8. use of oxygen;
  9. pregnancy or breastfeeding;
  10. poorly controlled diabetes;
  11. certain drugs such as phenytoin, carbamazepine, phenobarbital, rifampin, St. John's Wort, etc. (all medications will be reviwed/evaluated before subject enrollment)
IRB Number  
11-10-12B
Principal Investigator  
Higgins, Robert

For More Information, Contact  Sarah  , Norek
Phone:  (704) 355-1520  Fax:  (704) 355-9897  
Email:  Sarah.Norek@carolinashealthcare.org
Address:Blumenthal Cancer Center 1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204
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