Clinical trial · Interventional
Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma
NCT00047229CI-TRIAL-00030248completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- G3139 in combination with Doxorubicin
- interventionNames
- Biological: oblimersen sodium
- Drug: doxorubicin hydrochloride
Primary outcomes (1)
- measure
- Rate of objective response (complete and partial)
- timeFrame
- Up to 280 days
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Objective response rate of \>= 30% is considered active, and \<10% is considered inactive.
Secondary outcomes (6)
- measure
- Stable disease rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 2,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* 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
Renal
* Creatinine no greater than 1.25 times ULN OR
* Creatinine clearance at least 50 mL/min
Cardiovascular
* LVEF normal by MUGA
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 1 prior biologic therapy regimen for patients with HCC
* At least 4 weeks since prior biologic therapy
Chemotherapy
* 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 mitomycin)
* No prior doxorubicin, epirubicin, or other anthracycline
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No more than 3,000 cGy to fields including substantial bone marrow
Surgery
* At least 8 weeks since prior surgery
* Prior liver transplant for HCC allowed
Other
* 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 patientsReferences
Publications (2)
- RESULTKnox JJ, Chen XE, Feld R, Nematollahi M, Cheiken R, Pond G, Zwiebel JA, Gill S, Moore M. A phase I-II study of oblimersen sodium (G3139, Genasense) in combination with doxorubicin in advanced hepatocellular carcinoma (NCI # 5798). Invest New Drugs. 2008 Apr;26(2):193-4. doi: 10.1007/s10637-007-9104-1. Epub 2007 Dec 4. No abstract available. PMID 18060598
- RESULTKnox JJ, Chen E, Feld R, et al.: A phase II trial of oblimersen sodium (G3139) in combination with doxorubicin (DOX) in advanced hepatocellular carcinoma (HCC). NCI protocol # 5798. [Abstract] J Clin Oncol 24 (Suppl 18): A-14072, 2006.