Protocol No: | ECCT/11/10/01 | Date of Protocol: | 01-02-2013 |
Study Title: | A RANDOMIZED PHASE IIA TRIAL OF GEMCITABINE COMPARED WITH BLEOMYCIN PLUS VINCRISTINE FOR TREATMENT OF KAPOSI’S SARCOMA IN PATIENTS ON COMBINATION ANTIRETROVIRAL THERAPY IN WESTERN KENYA. |
Study Objectives: | |
Laymans Summary: | |
Abstract of Study: | Acquired Immune Deficiency Syndrome related Kaposi's sarcoma(AKS) is the most common cancer today in Western Kenya. Data from the Eldoret cancer registry shows that AKS accounts for 30% of all cancers seen in Uasin Gishu county. Data from Kenyatta National hospital shows that Patients with advanced AKS have a life expectancy of about six months if untreated. In addition, the standard treatment of combined anti-retroviral therapy(CART) with Bleomycin and Vincristine(BV) produces a complete response in only 25% of patients. A previous study of gemcitabine as a second line drug for AKS showed a response rate of 48% which is consistent with data from other centers that proves the efficacy of gemcitabine in soft tissue sarcomas. The high prevalence of AKS Coupled with debilitating morbidity and increased mortality despite treatment presents an unmet need for the population. Indirect efficacy data from gemcitabine justifies a proof of concept trial for gemcitabine in AKS. |