Status:
COMPLETED
Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Eli Lilly and Company
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 myelosuppres...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00315861
Start Date
March 1 2006
End Date
January 1 2009
Last Update
January 23 2009
Active Locations (1)
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1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023