A Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L with Erythropoietin Versus Above 100 G/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

Phase III GOG Study # 191, Activated 9/27/01

 

Eligibility Requirements:

 

Disease Characteristics

 

         Histologically confirmed primary, previously untreated, squamous cell carcinoma, adenocarcinoma, or

         adenosquamous carcinoma of the uterine cervix, Stage II-B, III-B, IV-A

 

         Hemoglobin level at presentation of <130 g/l

 

         Negative, non-suspicious para-aortic nodes

 

         No lower one-third vaginal involvement

 

         No carcinoma of cervical stump

 

Prior/Concurrent Therapy

 

         Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation

 

Patient Characteristics

 

         Performance Status of 0-3 (at least limited self care; confined to bed or chair no more than 50% of waking

         hours)

 

         Adequate bone marrow function, renal function and hepatic function.

 

         No septicemia or severe infection, uncontrolled hypertension, diagnosis of vitamin B₁₂ or folic acid

         deficiency, active hemolysis, recent uncontrolled seizure disorder, history of thrombotic vascular events

 

         No history of hypersensitivity to erythropoietin or human albumin

 

         If prior invasive malignancy, disease free for at least 5 years

 

         No concomitant malignancy except non-melanoma skin

 

Julia Chapman, M.D., is the Principal Investigator for this study.  Please contact Ruth Oben, RN, at (913) 588-4721 for more information or for patient registration.