Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

NCT00047229 | Completed Phase 2

• 3 other identifiers: PMH-PHL-011CDR0000257565NCI-5798
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Rate of objective response (complete and partial)

  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.

  Up to 280 days

Secondary Outcomes (6)

• Stable disease rate

  Up to 280 days

• Duration of response

  Up to 280 days

• Progression-free survival rate

  Up to 280 days

• Median survival rate

  Up to 280 days

• Overall survival rate

  Up to 280 days

Study Arms (1)

G3139 in combination with Doxorubicin

EXPERIMENTAL

Biological: oblimersen sodium; Drug: doxorubicin hydrochloride

Interventions

oblimersen sodium BIOLOGICAL

G3139 in combination with Doxorubicin

doxorubicin hydrochloride DRUG

G3139 in combination with Doxorubicin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Knox 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 RESULT

• Knox 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.

  RESULT

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

oblimersen; Doxorubicin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jennifer Knox, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2002
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

CA (3)