Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
Completed · Phase 1
Conditions studied: Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00315861
- Run by
- SCRI Development Innovations, LLC
- People needed
- 15
- Starts
- 2006-03-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2009-01-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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