Liver Cancer Clinical Trial
Official title:
A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma
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).
OBJECTIVES:
- 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.
;
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