A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Rate of objective response (complete and partial)
Jennifer Knox, MD
Princess Margaret Hospital, Canada
United States: Federal Government