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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Mesothelioma

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Trial Information

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


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.

PROJECTED ACCRUAL: A total of 15-41 patients will be accrued for this study within 6-18
months.

Inclusion 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:

Biologic therapy:

- Not specified

Chemotherapy:

- No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma

- No prior gemcitabine or anthracyclines

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No concurrent cimetidine

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Scott Okuno, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068659

NCT ID:

NCT00017186

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Medcenter One Health SystemBismarck, North Dakota  58501
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259