Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT00093418
Brief Summary:
This randomized phase II trial is studying 4 different tipifarnib regimens to compare how well they work in treating older patients with acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES:
I. To test whether any or all of four different regimens of R115777 (tipifarnib) is sufficiently effective therapy for previously untreated acute myeloid leukemia (AML) in patients of age 70 or older to warrant Phase III investigation. Additionally, to allow increased access for patients to an agent that appears promising in this patient population.
II. To estimate the frequency and severity of toxicities of these regimens in this group of patients.
III. To investigate in a preliminary manner the relationship of cytogenetics with response to R115777 (tipifarnib) and assess whether karyotype represents a potential prognostic factor among older AML patients who are not candidates for chemotherapy and are treated with R1157777.
IV. To collect specimens for future correlations (e.g. RAS and downstream targets) to be identified at a later date.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive oral tipifarnib twice daily on days 1-21. ARM II: Patients receive oral tipifarnib twice daily on days 1-7 and 15-21. ARM III: Patients receive tipifarnib as in arm I, but at a lower dose. ARM IV: Patients receive tipifarnib as in arm II, but at a lower dose.
In all arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients who achieve a complete remission (CR) receive up to 3 additional courses beyond CR. Patients in CR who develop recurrent disease after the completion of therapy are eligible to receive tipifarnib again.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Study:
NCT00093418
Study Brief:
Protocol Section:
NCT00093418