drugset / Trial / NCT00369629
Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome
Phase 1
Terminated
14 enrolled
Northwestern University
Eli Lilly and Company · collabNational Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more cancer cells. PURPOSE: This was planned as a phase I/II trial studying the side effects and determining the best dose of gemcitabine hydrochloride when given together with pemetrexed disodium. Unfortunately, due to a lack of funding, the phase II portion was never conducted.
Timeline
- Start
- 2006-08-28
- Primary completion
- 2012-07-16
- Completion
- 2013-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |