Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Eli Lilly and Company; GlaxoSmithKline
• Treatments: Pemetrexed; Topotecan

Criteria

Inclusion Criteria:

• Histologically proven advanced solid tumors

• Measurable or evaluable disease

• Age ≥ 18 years

• Karnofsky performance status ≥ 80% (ECOG 0 or 1)

• Adequate liver, bone marrow and kidney function

Exclusion Criteria:

• More than 3 prior chemotherapy regimens in the metastatic setting

• Prior treatment with topotecan or pemetrexed

• Clinically significant third space fluid present at the time of treatment

• Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs

• Inability to take steroid premedications or vitamin supplementation

• The presence of active brain metastases

• Prior radiotherapy within 4 weeks prior to the first day of treatment

• Prior surgery within 3 weeks prior to the first day of treatment

• Prior chemotherapy within 3 weeks prior to the first day of treatment