Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedepirubicin hydrochloride and gemcitabine hydrochloride

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 7, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Alliance for Clinical Trials in Oncology
Interventions being studied: Drug: epirubicin hydrochloride; Drug: gemcitabine hydrochloride

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma
At least 1 measurable lesion that can be accurately measured in at least one dimension
At least 20 mm (2 cm) in diameter PATIENT CHARACTERISTICS: Age:
18 and over Performance status:
ECOG 0-2 Life expectancy:
At least 12 weeks Hematopoietic:
Absolute neutrophil count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3 Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 3 times ULN Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular:
LVEF at least 50%
No history of congestive heart failure
No New York Heart Association class III or IV heart disease Other:
No uncontrolled infection
No other severe underlying disease that would preclude study participation
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Chemotherapy:
No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
No prior gemcitabine or anthracyclines Other:
No concurrent cimetidine

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

MBCCOP - Gulf CoastMobile, Alabama
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona
Mayo Clinic - JacksonvilleJacksonville, Florida
CCOP - Illinois Oncology Research AssociationPeoria, Illinois
CCOP - Carle Cancer CenterUrbana, Illinois
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
Siouxland Hematology-OncologySioux City, Iowa
CCOP - WichitaWichita, Kansas
CCOP - OchsnerNew Orleans, Louisiana
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan
CCOP - DuluthDuluth, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.

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