Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Brief Title

Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Official Title

Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma

Brief 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.
    

Detailed Description

      OBJECTIVES:

        -  Determine the antitumor activity of gemcitabine and epirubicin in patients with
           malignant pleural mesothelioma.

        -  Determine the toxicity of this regimen in this patient population.

        -  Determine the time to progression and overall survival of patients treated with this
           regimen.

        -  Assess quality of life in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1.
      Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses
      beyond CR.

      Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year.

      Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
      months for 3 years.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

time to progression

Secondary Outcome

 survival

Condition

Malignant Mesothelioma

Intervention

epirubicin hydrochloride

Study Arms / Comparison Groups

 gemcitabine + epirubicin

Description:  Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

69

Start Date

July 2001

Completion Date

May 2008

Primary Completion Date

August 2004

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Scott Okuno, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00017186

Organization ID

NCCTG-N0021

Secondary IDs

NCCTG-N0021

Responsible Party

Sponsor

Study Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Scott Okuno, MD, Study Chair, Mayo Clinic

Verification Date

December 2016