TAMPA, FloridaIrinotecan (Camptosar)/gemcitabine (Gemzar) combinations
are being studied in two lung cancer trials. Caio Max S. Rocha Lima, MD,
assistant professor of medicine at the University of South Florida’s H. Lee
Moffitt Cancer Center in Tampa, Florida, presented overviews of the protocols.
Dr. Rocha Lima first described Cancer and Leukemia Group B (CALGB) trial
39809, an ongoing phase II randomized study of gemcitabine/irinotecan and
gemcitabine/docetaxel (Taxotere) in previously untreated non-small-cell lung
cancer. The primary objective of this trial was to determine the response rates
of the two arms. Secondary objectives included assessing overall and
failure-free survival, duration of complete remissions, and toxicity. Efficacy
results are pending the completion of a median of 4 cycles of chemotherapy, but
Dr. Rocha Lima presented preliminary toxicity data.
"This trial was open to patients with histologically or cytologically
documented non-small-cell lung cancer who had measurable or evaluable
disease, Performance status 0 to 1, no prior chemotherapy, and no radiation
therapy more recently than 2 weeks before study entry," Dr. Rocha Lima
The protocol called for accrual of 36 patients per arm, which provided a 90%
power to differentiate between 20% and 40% response rates. Patients were
stratified according to stage, presence of central nervous system metastasis,
and recurrent vs newly diagnosed disease.
"Eighty patients have been enrolled, and we have preliminary analysis
based on the first 64 patients, 63 of whom met eligibility requirements, and a
median of two cycles of therapy," Dr. Rocha Lima said. Twenty percent of
patients in each arm had brain metastases.
Grade 3 and 4 hematologic toxicities were comparable between the two
regimens. Grade 3 and 4 nonhematologic toxicities were uncommon and
incomparable in both arms except for nausea and vomiting. "Grade 3
diarrhea occurred in 10% of patients on gemcitabine/irinotecan and in 7% of
patients on gemcitabine/docetaxel, but it is notable that there was no grade 4
diarrhea in either arm," Dr. Rocha Lima said. There was one early death on
each arm of the study.