Title
Phase I study of weekly bortezomib (Velcade) and weekly topotecan in solid tumor
patients with an emphasis on small cell lung cancer.
What are the goals of this study?
Topotecan is a synthetic camptothecin, a compound derived from the bark of the
Chinese camptotheca tree. The drug is a topoisomerase inhibitor that works by
blocking an enzyme, topoisomerase, which is responsible for maintaining the structural
function and integrity of DNA. By inhibiting topoisomerase, topotecan ultimately
causes cancer cell death.
Bortezomib is a proteasome inhibitor that works by blocking the proteasome, an
enzyme complex found in cells, and interfering with the chemical messengers that
control cancer cell growth and regulate cell survival. This results in a variety of anticancer
effects, including cancer cell death.
Previous research has shown that bortezomib can enhance the sensitivity of camptothecins.
This Phase I study is designed to evaluate the safety and feasibility of
combining the two drugs to treat patients with advanced solid tumors. If the results
are favorable, a Phase II trial will be developed in specific tumor types, such as small
cell lung cancer, to evaluate whether the two drugs combined are more effective
than topotecan alone.
Background
About two-thirds of patients with small cell lung cancer have advanced or extensive
disease when their cancer is first found. The standard treatment for these patients is a
combination of the drugs etoposide, another topoisomerase inhibitor, and cisplatin or
carboplatin. Treatment for patients with advanced disease, however, is rarely curative.
Researchers are testing new drugs and drug combinations in patients with extensivestage
small cell lung cancer in an effort to improve the median survival time, now
about 10 months.
Who can join this trial?
Researchers seek to enroll 34 patients ages 18 and over with advanced solid tumors who have progressive disease after their standard therapy. For a complete list of eligibility criteria, please call Jennifer Jernigan at (916) 734-7094.
Where is this trial taking place?
This study is offered only at UC Davis Cancer Center.
Principal investigator:
Angela Davies, assistant professor of medicine, hematology and oncology,
UC Davis.
For more information about this or other clinical trials available at UC Davis Cancer
Center, please visit www.ucdaviscancerclinicaltrials.org.
This trial is sponsored by GlaxoSmithKline
