NCT00024271

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs directly into the tumor after surgery and combining them with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and radiation therapy in treating patients who have peritoneal cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2004

First QC Date

September 13, 2001

Last Update Submit

January 3, 2014

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesotheliomaadvanced malignant mesotheliomarecurrent malignant mesothelioma

Interventions

recombinant interferon gammaBIOLOGICAL
cisplatinDRUG
doxorubicin hydrochlorideDRUG
gemcitabine hydrochlorideDRUG
mitomycin CDRUG
conventional surgeryPROCEDURE
hyperthermia treatmentPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant mesothelioma * Measurable or evaluable disease * Ineligible for other high-priority study * No CNS metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * SWOG 0-2 * Karnofsky 60-100% Life expectancy: * More than 2 months Hematopoietic: * WBC greater than 3,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times normal Renal: * Creatinine clearance at least 45 mL/min * BUN less than 1.5 times normal * No significant calcium abnormalities Cardiovascular: * No symptomatic cardiovascular disease * No New York Heart Association class II, III, or IV heart disease * No congestive heart failure * No angina pectoris * No cardiac arrhythmia * No uncontrolled hypertension Other: * No significant phosphate, electrolyte, or other metabolic abnormalities (e.g., metabolic acidosis) * No uncontrolled psychiatric disorder or neurologic disease * No seizure disorder * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer * No other serious medical or psychiatric illness * No uncontrolled serious infection * No senility or emotional instability * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 2 prior chemotherapy regimens * No more than 1 prior intraperitoneal chemotherapy regimen * More than 6 weeks since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) * Concurrent steroids for antiemesis, premedication, adrenal failure, or septic shock allowed Radiotherapy: * No prior abdominal, pelvic, or lower chest radiotherapy Surgery: * Prior surgical resection preceding disease recurrence allowed * More than 1 week since prior surgery

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Interferon-gammaCisplatinDoxorubicinGemcitabineMitomycinDiathermyRadiotherapy

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingMitomycinsIndolequinonesQuinonesAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHyperthermia, InducedTherapeutics

Study Officials

  • Robert N. Taub, MD, PhD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

May 1, 2001

Last Updated

January 6, 2014

Record last verified: 2004-01

Locations

US(1)