Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
RATIONALE: Drugs used in chemotherapy such as doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with doxorubicin in treating patients who have locally advanced, recurrent, or metastatic hepatocellular carcinoma (liver cancer).
Biological: oblimersen sodium
Drug: doxorubicin hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma|
- Rate of objective response (complete and partial) [ Designated as safety issue: No ]
- Stable disease rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Progression-free survival rate [ Designated as safety issue: No ]
- Median survival rate [ Designated as safety issue: No ]
- Overall survival rate [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||October 2002|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of oblimersen and doxorubicin in patients with advanced hepatocellular carcinoma or other incurable solid tumor (closed to accrual as of 11/7/03). (Phase I completed as of 1/16/04.)
- Determine the efficacy of this regimen, in terms of objective response rate, in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression, response duration, progression-free survival, median survival, and overall survival rates in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. (Phase I completed as of 1/16/04.)
Patients receive oblimersen IV continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen and doxorubicin 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. Once the MTD is determined, additional patients*, including 6 patients with hepatocellular carcinoma (HCC), are treated at the recommended phase II dose. (Phase I completed as of 1/16/04.)
NOTE: *Other solid tumors closed to accrual as of 11/7/03; only accruing HCC patients
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for the phase I portion of this study within 6 months (phase I completed as of 1/16/04). A total of 30 patients will be accrued for the phase II portion of this study within 10-15 months.
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Jennifer Knox, MD||Princess Margaret Hospital, Canada|