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A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Not Enrolling
Liver Cancer

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Trial Information

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.

Inclusion Criteria


- Diagnosis of 1 of the following:

- Histologically or cytologically confirmed hepatocellular carcinoma (HCC)

- Locally advanced, recurrent, or metastatic

- Not candidates for surgical/radical therapies

- Other solid tumor that is incurable (closed to accrual as of 11/7/03)

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Target lesion may not be in a previously irradiated field unless subsequent
progression was documented

- No ascites

- No known brain metastases



- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 3 months


- WBC at least 2,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 5 times upper limit of normal (ULN)

- Albumin greater than 3.5 g/dL

- No cirrhosis worse than Childs-Pugh class A


- Creatinine no greater than 1.25 times ULN OR

- Creatinine clearance at least 50 mL/min


- LVEF normal by MUGA

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- Good nutritional status

- No encephalopathy

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study participation

- No prior allergic reactions to compounds of similar chemical or biological
composition to oblimersen or doxorubicin

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy

- No more than 1 prior biologic therapy regimen for patients with HCC

- At least 4 weeks since prior biologic therapy


- Patients with HCC:

- No prior systemic chemotherapy

- Prior chemotherapy as part of localized chemoembolization therapy may be allowed
(no more than 150 mg/m^2 for doxorubicin) if completed at least 8 weeks before
study treatment

- All other patients (closed to accrual as of 11/7/03):

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or

- No prior doxorubicin, epirubicin, or other anthracycline

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No more than 3,000 cGy to fields including substantial bone marrow


- At least 8 weeks since prior surgery

- Prior liver transplant for HCC allowed


- Recovered from all prior therapy

- At least 8 weeks since other locally ablative therapies

- No concurrent commercial or other investigational agents or therapies

- No other concurrent anticancer therapy

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of objective response (complete and partial)

Safety Issue:


Principal Investigator

Jennifer Knox, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular