NCT00093444

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells. PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given with radiofrequency ablation in treating patients with primary or metastatic liver tumors.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

First QC Date

October 6, 2004

Last Update Submit

March 14, 2012

Conditions

Liver CancerMetastatic Cancer

Keywords

advanced adult primary liver cancerliver metastaseslocalized unresectable adult primary liver cancerrecurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of heat-activated doxorubicin HCL liposome

  • Pharmacokinetics and pharmacodynamics of heat-activated doxorubicin HCL liposome at 15, 30, 45, 60, 75, and 90 minutes; 2, 3, 4, 6, 24, and 46 hours; and 4 and 8 days following infusion

Secondary Outcomes (1)

  • Effects of ablative therapy on tumor blood flow and tumor vascular density as measured by MRI at 28 days following study completion

Interventions

lyso-thermosensitive liposomal doxorubicinDRUG
radiofrequency ablationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed tumor of the liver * Primary or metastatic disease * No more than 4 lesions * No single lesion \> 7 cm in maximum diameter * Not a candidate for curative surgical resection due to tumor histology or prior surgery PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Platelet count ≥ 75,000/mm\^3 * WBC ≥ 1,500/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusions to attain levels ≥ 10g/dL allowed) Hepatic * Bilirubin ≤ 2.0 mg/dL * PT or PTT ≤ 1.5 times control (except for patients receiving anticoagulation therapy for an unrelated medical condition \[e.g., atrial fibrillation\]) Renal * Creatinine ≤ 2.5 mg/dL Cardiovascular * See Hepatic * Ejection fraction ≥ 50% by MUGA * No congestive heart failure * No myocardial infarction within the past 6 months * No cerebral vascular accident within the past 6 months * No life-threatening cardiac arrhythmia Other * Weight \< 136 kg * Glucose ≤ 300 mg/dL * No uncontrolled diabetes * No known serious uncontrolled reaction (e.g., anaphylaxis) to contrast agents used in this study * No known allergy to egg or egg products * No other serious medical illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent interferon * No live vaccines (for immunosuppressed patients only) during and for 30 days after study treatment Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics Other * More than 3 weeks since prior therapy for liver tumor(s) * More than 3 weeks since prior systemic therapy for non-life-threatening extrahepatic disease and recovered * No other concurrent systemic therapy * No administration of any of the following medications during and for 30 days after study treatment: * Cyclosporine * Phenobarbital * Phenytoin * Streptozocin * No concurrent administration of any of the following medications: * Amphotericin B by injection * Antithyroid agents for overactive thyroid * Azathioprine * Chloramphenicol * Colchicine * Flucytosine * Ganciclovir * Plicamycin * Zidovudine * Probenecid * Sulfinpyrazone

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Queen Mary Hospital - Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm MetastasisCarcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Bradford Wood, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Study Start

September 1, 2004

Study Completion

January 1, 2010

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(1)CN(1)