NCT00019786

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Aug 1999

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

First QC Date

July 11, 2001

Last Update Submit

March 21, 2012

Conditions

Colorectal CancerIslet Cell TumorLiver CancerMetastatic CancerNeuroendocrine Carcinoma

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerrecurrent islet cell carcinomaadult primary hepatocellular carcinomaadenocarcinoma of the colonadenocarcinoma of the rectumliver metastasesadult primary cholangiocellular carcinomaadvanced adult primary liver cancerrecurrent childhood liver cancerchildhood hepatocellular carcinomastage III childhood liver cancerstage IV childhood liver cancerneuroendocrine carcinoma

Outcome Measures

Primary Outcomes (5)

  • Response rate

  • Duration of response

  • Patterns of recurrence

  • Disease-free survival

  • Overall survival

Interventions

isolated perfusionDRUG
melphalanDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically proven liver cancer meeting 1 of the following criteria: * Primary unresectable hepatocellular or cholangiocellular carcinoma * Metastatic cancer to the liver originating from one of the following: * Intraocular melanoma (closed to accrual as of 10/17/03) * Islet cell carcinoma * Adenocarcinoma of the colon or rectum limited to parenchyma of the liver * No evidence of other unresectable extrahepatic colorectal metastasis * Other neuroendocrine tumors, such as carcinoid tumors * Measurable disease PATIENT CHARACTERISTICS: Age: * Any age Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 27.0% * WBC at least 2,500/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) * PT no greater than 2 seconds above upper limit of normal * Elevated SGOT and SGPT allowed if not due to hepatitis * No biopsy-proven cirrhosis or evidence of significant portal hypertension * No prior or concurrent veno-occlusive disease * Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * Congestive heart failure allowed if LVEF ≥ 40% Pulmonary: * No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age Other: * Weight greater than 30 kg * Not pregnant or nursing * Negative pregnancy test * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior anticancer biologic therapy and recovered Chemotherapy: * At least 1 month since prior anticancer chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since prior anticancer radiotherapy and recovered Surgery: * Not specified Other: * Prior intrahepatic arterial infusion therapy allowed * No chronic use of anticoagulants * No concurrent immunosuppressive therapy

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Feldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7. doi: 10.1200/JCO.2003.04.150.

    PMID: 14673042RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsAdenoma, Islet CellLiver NeoplasmsNeoplasm MetastasisCarcinoma, NeuroendocrineColonic NeoplasmsRectal NeoplasmsCarcinoma, HepatocellularCarcinoma, Islet Cell

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatic NeoplasmsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinomaCarcinomaNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • H. Richard Alexander, MD, FACS

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 1999

Study Completion

January 1, 2006

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

US(1)