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AzTrials

Liver CancerPhase 2NCT00047229

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

A Phase 2 study testing oblimersen sodium and doxorubicin hydrochloride in people with Liver Cancer, run by University Health Network, Toronto at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Liver Cancer
What is being tested?
oblimersen sodium and doxorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesCanada
Study dates
Oct 2002to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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).

Read the detailed description

OBJECTIVES:

  • 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 patients.
  • 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.

Conditions
Liver Cancer
Being tested
oblimersen sodium, doxorubicin hydrochloride
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00047229
Study groupRoleWhat they receive
G3139 in combination with DoxorubicinExperimentalNot described
Receives: Biological: oblimersen sodium; Drug: doxorubicin hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 280 days

Secondary outcomes (6)

  1. Stable disease rate

    Measured: Up to 280 days

  2. Duration of response

    Measured: Up to 280 days

  3. Progression-free survival rate

    Measured: Up to 280 days

  4. Median survival rate

    Measured: Up to 280 days

  5. Overall survival rate

    Measured: Up to 280 days

  6. Safety and tolerability

    Measured: Up to 280 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2002
  3. Primary completionJan 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047229
Sponsor's protocol ID
PMH-PHL-011
Other IDs
CDR0000257565, NCI-5798
Status last verified
Nov 2017
First submitted
3 Oct 2002
Last updated
8 Nov 2017
Results posted
No

Publications

  • 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.

    PubMed 18060598

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oblimersen sodium and doxorubicin hydrochloride in people with Liver Cancer, run by University Health Network, Toronto at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of objective response (complete and partial) (time frame: Up to 280 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00047229, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.

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