drugset / Trial / NCT00602771
Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II trial is studying the side effects and how well giving tipifarnib together with etoposide works in treating older patients with newly diagnosed, previously untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells.
Timeline
- Start
- 2008-01
- Primary completion
- 2011-10
- Completion
- 2011-10
Publications
- Ding H, McDonald JS, Yun S, Schneider PA, Peterson KL, Flatten KS, Loegering DA, Oberg AL, Riska SM, Huang S, Sinicrope FA, Adjei AA, Karp JE, Meng XW, Kaufmann SH. Farnesyltransferase inhibitor tipifarnib inhibits Rheb prenylation and stabilizes Bax in acute myelogenous leukemia cells. Haematologica. 2014 Jan;99(1):60-9. doi: 10.3324/haematol.2013.087734. Epub 2013 Aug 30.
- Karp JE, Vener TI, Raponi M, Ritchie EK, Smith BD, Gore SD, Morris LE, Feldman EJ, Greer JM, Malek S, Carraway HE, Ironside V, Galkin S, Levis MJ, McDevitt MA, Roboz GR, Gocke CD, Derecho C, Palma J, Wang Y, Kaufmann SH, Wright JJ, Garret-Mayer E. Multi-institutional phase 2 clinical and pharmacogenomic trial of tipifarnib plus etoposide for elderly adults with newly diagnosed acute myelogenous leukemia. Blood. 2012 Jan 5;119(1):55-63. doi: 10.1182/blood-2011-08-370825. Epub 2011 Oct 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etoposide | Small molecule | 100 mg | Oral |
| Subject | Etoposide | Small molecule | 200 mg | Oral |
| Subject | tipifarnib | Small molecule | 400 mg | Oral |
| Subject | tipifarnib | Small molecule | 600 mg | Oral |
Indications
acute erythroid leukemia
acute megakaryoblastic leukemia in adult
acute myeloblastic leukemia with maturation
acute myeloblastic leukemia without maturation
acute myeloid leukemia with 11q23 abnormalities
acute myeloid leukemia with minimal differentiation
acute myeloid leukemia with multilineage dysplasia
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, del(5q31-q32)
acute myeloid leukemia, inv(16)(p13.1;q22)
acute myeloid leukemia, t(16;16)(p13.1;q22)
acute myelomonocytic leukemia M4
adult acute monocytic leukemia
therapy related acute myeloid leukemia and myelodysplastic syndrome