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Gemzar study

A randomized phase 11a trial of gemcitabine compared with bleomycin plus vincristine for treatment of Kaposi's sarcomain patients on combination antiretroviral therapy in western kenya

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201510001143243
Enrollment
70
Registered
2015-05-15
Start date
2014-05-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cancer

Interventions

Gemcitabine
Bleomycin plus Vincristine

Sponsors

AMPATH Oncology Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically confirmed Kaposi's sarcoma Documented HIV positive state Documented CD4 cell count Signed informed consent form Stage T0 should have taken ARVs for at least 8 weeks Age over 18 years Adequate hematologic function i.e neutrophil count more than 1000/microliter of bllod,plateles more than 75000 and HB more tha 10grams Creatinine level less tha 200mocrograms per ml of blood ECOG score less than 2 Negative pregnancy test with dual contraception for women of reproductive age

Exclusion criteria

Exclusion criteria: Previous treatment with chemotherapy or radiotherapy Unmeasurable KS lesions Concurrent febrile illneses Concurrent malignancy Allergic reaction to any of the study drugs Breast feeding

Design outcomes

Primary

MeasureTime frame
Response rate, both complete and partial in both study arms. Response will be made by reduction ins-size through bi-directional measurement.;Descrition of drug-associated adverse effects in both arms;Patient quality of life in both arms

Countries

Kenya

Contacts

Public ContactJob Kisuya

Research Manager

jobiwapash@yahoo.com+254721884347

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026