DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: DJ-927 Drug: capecitabine||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors|
|Study Start Date:||February 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of DJ-927 and capecitabine in patients with locally advanced or metastatic solid tumors.
- Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.
- Determine the toxicity profile of this regimen in these patients.
- Determine the possible pharmacokinetic interactions of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation, nonrandomized, multicenter study.
- Course 1: Patients receive oral DJ-927 once on day 1 and oral capecitabine once on days 0 and 1 and twice daily on days 2-14.
- Course 2: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 2-15.
- Course 3 and all subsequent courses: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 1-14.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of DJ-927 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients receive treatment at the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077077
|United States, Alabama|
|Comprehensive Cancer Center at University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Texas|
|Cancer Therapy and Research Center|
|San Antonio, Texas, United States, 78229|
|OverallOfficial:||Chris H. Takimoto, MD, PhD, FACP||Cancer Therapy and Research Center, Texas|