Eduardo Cazap, MD, PhD
Founder, Latin American and Caribbean Society of Medical Oncology (SLACOM)
Immediate Past President, International Union again Cancer (UICC)
Buenos Aires, Argentina
2013-2014 BCRF Project:
The purpose of the multi-center, international clinical trial led by Dr. Cazap and funded by BCRF, is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer. The novel schedule of capecitabine dosing based upon Norton-Simon mathematical modeling will be compared with the standard dosing schedule of capecitabine. The trial’s secondary objectives are to compare the safety and tolerability, response rate and rate of stable disease after more than six months of these two capecitabine dosing schedules.
This trial from SLACOM researchers is a continuation of several years of work in breast cancer in Latin America and is the first example in Latin America of a clinical trial supported by BCRF, independent of industry support. A feasibility study was previously done in order to evaluate which countries and sites were suitable for the study according with the patient characteristics, potential number of patients to be accrued, quality of data and follow-up. Four countries and up to 15 sites have been involved in this trial.
Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug, and Phase I and II studies done at Memorial Sloan Kettering Cancer Center support the tolerability of this scheme.
Dr. Cazap hypothesizes that this definitive, randomized, phase III trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer will be superior in terms of efficacy.
Dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. This trial is a proof of principle trial of the highest priority.
Four Latin American countries are now participating in this study: Argentina, Chile, Peru and Mexico. Independent groups are working in collaboration with investigators from National Cancer Institutes of Brazil and Mexico.
All the Pre-study and Study Set-up activities for the trial are completed and fully operational, and the regulatory obstacles have been resolved. Supply of the study drug has been secured in all participating countries with the corresponding agreements with the vendors and logistics companies.
The protocol was approved by the National Ethical Committee in Argentina and the first site was opened for accrual in 2013. The researchers expect the other sites (19) to open no later than mid-February 2014. Agreements were reached with the National Cancer Institute in México and the Instituto de Enfermedades Neoplasticas (INEN) in Peru to have them as the main sites in both countries. The CRO engaged for this trial began activity in Brazil making 12 visits to pre-selected sites in Sao Pablo and Rio de Janeiro, and agreements have been initiated with the principal investigators at. Finally, during the past six months the research team had multiple face-to-face meetings with the principal investigators and their medical teams to reinforce their commitment with the project.
Eduardo Cazap is the founder and first President of the Latin American & Caribbean Society of Medical Oncology (SLACOM) since 2004. In 2008 he was elected by the General Assembly of the International Union against Cancer (UICC) as President for the 2010-2012 term.
After graduating in 1972 as a medical doctor from the University of Buenos Aires in his native city, Dr. Cazap was resident in Internal Medicine and then specialist in medical oncology at the Military Central Hospital and the Universidad del Salvador. He also completed fellowships at Strong Memorial Hospital, Rochester, New York and the Lombardi Cancer Center at Georgetown University, Washington, D.C. He was also fellow of the American Cancer Society in 1985. Following his role as Principal Investigator of the Collaborative Cancer Research Treatment Program (PAHO- NCI) in 1984, he became Professor of Clinical Oncology at the Universidad del Salvador (1984-98) and then Professor of Medical Oncology at the Universidad Catolica Argentina (1988-2000).
As well as having published over 170 papers, he has held many prominent positions in the medical arena, including Medical Director of the Instituto Dr. Estevez, Buenos Aires (1985-99) and representing Latin America at the European Society of Medical Oncology (ESMO), Lugano, Switzerland. He was President of the Argentine Association of Clinical Oncology (AAOC) in 1996-98 and 2000-02. In 2000, he signed the Charter of Paris against Cancer. He has been a member of the Developing Countries Task Force for ESMO since 2002. Dr. Cazap was a member of the 2006 and 2008 UICC World Congress Program Planning Executive Committee. He is an active member of American Society of Clinical Oncology (ASCO), was Chairman of ASCO's International Affairs Committee, is member of the Cancer Prevention Committee and was also recently elected to the ASCO Board of Directors representing the international members. Dr. Cazap also chairs the International Clinical Trials Working Group (ICTWG), a joint effort of ASCO and the National Cancer Institute, aimed at the improvement of independent clinical cancer research at the international level. He also leads the International Cancer Prevention Stakeholders Group, under the umbrella of UICC and with the support of ASCO, to coordinate international activities and a common strategy in cancer prevention towards improvement of global cancer control.