Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available.
The purpose of this study is to find the answers to the following research questions:
- What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days?
- What are the side effects of clofarabine when given on this schedule?
- How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug?
- Will oral clofarabine help treat solid tumor cancer?
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation and Pharmacokinetic Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors|
- To determine the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) and dose limiting toxicity (DLT) of oral clofarabine when administered once daily for 5 days every 28 days to adult patients with locally advanced or metastatic solid tumors [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Study Completion Date:||February 2006|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
Single-arm, dose escalation
Drug: clofarabine (oral formulation)
Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.
|United States, Texas|
|Mary Crowley Medical Research Center|
|Dallas, Texas, United States, 75246|
|Tyler Cancer Institute|
|Tyler, Texas, United States, 75702|
|United States, Washington|
|Cancer Care Northwest|
|Spokane, Washington, United States, 99218|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|