Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201510001143243 Date of Registration: 15/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gemzar study
Official scientific title 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
Brief summary describing the background and objectives of the trial HIV-related Kaposi's sarcoma is now the most common cancer affecting patients in the oncology clinic in eldoret.Patients are typically treated by combining vincristine and bleomycin but response rates are just about 30% of those treated. Alternative, more effective drugs are needed and gemcitabine is one of those drugs that have shown response rates with fewer side effects in this set up. We have observational data on gemcitabine when used as a second line drug after failure of bleomycin, vincristine and doxorubicin cobination. This prelimary observational study produced a 48% response rate. This study is going to be done at Moi Teaching and Referral Hospital which is the largest referral hospital in western kenya.At this hospital, the oncology division is part of a large HIV program called the Academic Model Providing Access to Health Care(AMPATH) and treats approximately 20 new patients with KS per month. Both nurses, clinical officers and Doctors routinely use gemcitabine for the treatment of pancreatic and bladder cancer and as a second line drug for breast cancer and Kaposi's sarcoma. The main objective of this study is to determine the complete response rate to treatment with gemcitabine compared to the combination of bleomycin and vincristine. The other objectives are to determine the population pharmacokinetics of gemcitabine,document gemcitabine-related toxicity and quality of life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2014
Actual trial start date 02/05/2014
Anticipated date of last follow up 15/09/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IREC/2009/93 institutional research and ethics committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using research electronic data capture(REDCAP) randmization software to ensure equal representation in both arms. By use of sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Gemcitabine 1000mg/m2 every 2 weeks 3 cycles Gemcitabine 35 Active-Treatment of Control Group
Control Group Bleomycin plus Vincristine Bleomycin 10mg/m2 plus Vincristine 1.2mg/m2 twice weekly 6 weeks Bleomycin plus Vincristine 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 Previous treatment with chemotherapy or radiotherapy Unmeasurable KS lesions Concurrent febrile illneses Concurrent malignancy Allergic reaction to any of the study drugs Breast feeding 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Institutional research and ethics committee
Ethics Committee Address
Street address City Postal code Country
Nandi Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Response rate, both complete and partial in both study arms. Response will be made by reduction ins-size through bi-directional measurement. 2weeks, 4 weeks, 6 weeks
Primary Outcome Descrition of drug-associated adverse effects in both arms At study initiation, 2 weeks, 4 weeks and 6 weeks
Primary Outcome Patient quality of life in both arms At 2 weeks, 4 weeks, and 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Moi Teaching and Referral Hospital Nandi Street Eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
AMPATH Oncology Institute Nandi Street Eldoret 30100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AMPATH Oncology Institute Nandi Street Eldoret 30100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Paul Waako Mulago Kampala 7010 Uganda
Patrick Loehrer Barnhill Indianapolis 46202 United States of America
Matthew Strother Christchurch Canterbury 4710 New Zealand
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naftali Busakhala nbusakhala@yahoo.com +254722496933 Nandi
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Physician/Oncologist
Role Name Email Phone Street address
Public Enquiries Job Kisuya jobiwapash@yahoo.com +254721884347 Nandi
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Research Manager
Role Name Email Phone Street address
Scientific Enquiries Gabriel Kigen kigengfk@gmail.com +25 571 584 7896 Nandi
City Postal code Country Position/Affiliation
Eldoret 30100 Kenya Oncology Pharmacist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information