Clinical Trials Directory

Trials / Completed

CompletedNCT00315861

Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
SCRI Development Innovations, LLC · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
DRUGpemetrexed
DRUGtopotecan

Timeline

Start date
2006-03-01
Primary completion
2008-05-01
Completion
2009-01-01
First posted
2006-04-19
Last updated
2009-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00315861. Inclusion in this directory is not an endorsement.