A Phase II Evaluation of Flavopiridol in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase II GOG Study # 129-M, Activated 10/23/0, Currently suspended for interim analysis.

 

Eligibility Requirements:

 

Disease Characteristics

 

         Histologically confirmed persistent or recurrent endometrial carcinoma whose potential for cure by

         standard treatment is very poor

 

         Measurable disease

 

Prior/Concurrent Therapy

 

         Recovered from effects of recent surgery, radiation therapy or chemotherapy.  At least 3 weeks since

         any prior therapy directed at malignant tumor.  Free of significant infection.

 

         Any hormonal therapy directed at the malignant tumor much be discontinued at least 1 week prior to

         registration.  Continuation of HRT is okay.

 

         Exactly 1 prior chemotherapy regimen (either single or combination cytotoxic drug therapy)

 

         No prior therapy with cyclin dependent kinase inhibitors

 

Patient Characteristics

 

Performance status 0-2 (ambulatory, capable of self care, up at least 50% of waking hours)

 

No history of thromboembolic events, thrombophlebitis, recent MI, angina, CVA or TIA

 

No history of re-vacularization procedures within previous 6 months

 

No concomitant malignancy other than non-melanoma skin.  Prior malignancy okay if disease-free >5 years and if no prior chemotherapy for that malignancy.

 

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