Lung Cancer Clinical Trial
Official title:
A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
Currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily combined. This phase I trial will evaluate the safety and tolerability of weekly topotecan in combination with pemetrexed in patients with advanced solid tumors.
Three patients will be accrued at each of 5 dose levels. Dose escalation will only proceed
if none of the additional 3 patients experience DLT. The highest dose level that generates
DLT in 0/3 or 1/6 patients will be the maximum tolerated dose (MTD) or the doses recommended
for subsequent studies. A total of 10 patients will be treated at the MTD to further assess
the toxicity of the dosing regimen and its suitability for use in subsequent trials.
Patients may continue to receive treatment until unacceptable toxicity or disease
progression is encountered. Treatment cycles will be repeated every 21 days. The protocol is
also designed to enroll an additional 10 patients at the maximum tolerated dose to increase
the confidence in the safety and suitability of the doses that are chosen for subsequent
studies.
- Topotecan Day 1 and 8
- Pemetrexed Day 1
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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