Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy 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. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs.
PURPOSE: Phase I/II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and leucovorin with oblimersen in treating patients who have unresectable, metastatic, or recurrent colorectal cancer.
Biological: oblimersen sodium
Drug: leucovorin calcium
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Oblimersen Sodium (G3139, Genasense) in Combination With Oxaliplatin, 5FU and Leucovorin (FOLFOX4) Regimen in Advanced Colorectal Cancer|
|Study Start Date:||October 2002|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of oblimersen when administered with oxaliplatin, fluorouracil, and leucovorin calcium in patients with advanced colorectal cancer.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
- Determine the plasma pharmacokinetics of oblimersen and oxaliplatin in patients treated with this regimen.
- Determine relevant predictive biomarkers of response in patients treated with this regimen.
OUTLINE: This is an open-label, phase I, dose-escalation study of oblimersen followed by a non-randomized, phase II study.
- Phase I: Patients receive oblimersen IV continuously on days 1-5 and 15-19; leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 6, 7, 20, and 21; and oxaliplatin IV over 2 hours on days 6 and 20.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
- Phase II: Up to 35 additional patients are treated as in phase I, with oblimersen at the MTD.
In both phases, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 6-53 patients (6-18 patients for phase I and 12-35 patients for phase II) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055822
|United States, Texas|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229-3264|
|Study Chair:||Anthony W. Tolcher, MD||San Antonio Cancer Institute|