Research and Clinical Trials

Title  
GOG 0129Q: A Phase II Evaluation of Gemcitabine in the Treatment of Recurrent or Persistant Endometrial Cancer
Brief Description  
The purpose of this trial is to study the side effects of Gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer.
Who may be Eligible  

  • Histologically confirmed endometrial adenocarcinoma
    • Recurrent or persistent disease
    • Refractory to curative therapy or established treatments
  • Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
    • Initial treatment may have included non-cytotoxic agents or high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
    • No more than one prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
  • Not pregnant or nursing
  • No neuropathy (sensory and motor) > grade 1
  • No active infection requiring antibiotics (except an uncomplicated urinary tract infection)
  • No other invasive malignancies within the past 5 years except non-melanoma skin cancer
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior hormonal therapy for endometrial cancer
  • At least 3 weeks since prior biological therapy, immunotherapy, or other therapy for endometrial cancer
  • At least 4 weeks since prior radiotherapy
  • More than 3 years since prior radiotherapy for localized breast cancer, head and neck cancer, or skin cancer and
    • No recurrent or persistent breast cancer, head and neck cancer, or skin cancer
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer
    • No recurrent or metastatic breast cancer
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
  • No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
  • No prior gemcitabine hydrochloride
Speciality/Disorder  
Gynecological Cancer
IRB Number  
03-09-06A
Principal Investigator  
Tait, David

For More Information, Contact  Mary Frances  , Bussey
Phone:  (704) 355-7627  Fax:  (704) 355-1188  
Email:  Mary.Bussey@carolinashealthcare.org
Address:1025 Morehead Medical Drive
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