Breast Cancer Clinical Trial
Official title:
A Phase I/IIA Dose-Escalating Trial of BCL-2 Antisense (G3139) Treatment for Patients With Androgen-Independent Prostate Cancer or Other Advanced Solid Tumor Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of oblimersen in treating patients who
have solid tumors that have not responded to previous therapy.
OBJECTIVES: I. Evaluate the safety and plasma concentration profiles of oblimersen (G3139)
administered alone or in combination with docetaxel in patients with advanced solid tumors
expressing the bcl-2 oncogene. II. Determine the plasma concentration profiles, maximum
tolerated dose (MTD), and/or optimal biologic dose (OBD) of this treatment regimen in these
patients. III. Determine the antitumor effects of G3139, at the MTD or OBD, in combination
with docetaxel in patients with androgen-independent, refractory, or recurrent prostate
cancer.
OUTLINE: This is a dose-escalation study of oblimersen (G3139). Phase I: Patients receive
G3139 IV on days 1-5 and docetaxel IV on day 5. Treatment repeats every 21 days for up to 6
courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which no more than 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity. Phase II: Patients receive G3139 continuously over 21
days at one dose level below the MTD in combination with weekly docetaxel. Patients receive
up to 2 more courses of therapy in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A maximum of 57 patients (42 for phase I and 15 for phase II) will be
accrued for this study.
;
Primary Purpose: Treatment
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