Gemcitabine and Epirubicin in Treating Patients with Malignant Mesothelioma

http://www.clinicaltrials.gov/ct/show/NCT00017186?amp;order=5

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.

OBJECTIVES:

  • Determine the anti-tumor 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.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Location and Contact Information

Alabama

MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013

Arizona

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875

Florida

Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Edith A. Perez, MD 904-953-0118 perez.edith@mayo.edu

Illinois

CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com

CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61602, United States; Recruiting
John W. Kugler, MD 309-636-3605

Iowa

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD 515-244-7586

Siouxland Hematology-Oncology, Sioux City, Iowa, 51101-1733, United States; Recruiting
Donald Bruce Wender, MD, PhD 712-252-0088 shoa@pionet.net

Kansas

CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD 316-268-5784

Louisiana

CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910

Michigan

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 877-590-5995

Minnesota

CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Daniel Nikcevich, MD, PhD 218-786-3625 dnikcevich@smdc.org

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com

CentraCare Health Plaza, Saint Cloud, Minnesota, 56303, United States; Recruiting
Harold E. Windschitl, MD 320-229-5199 schosp@cloudnet.com

Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Scott Okuno, MD 507-284-2511

Nebraska

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc

North Dakota

CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Preston D. Steen, MD 701-234-6161

Medcenter One Health System, Bismarck, North Dakota, 58501-5505, United States; Recruiting
Edward Wos, DO 701-323-5741 ejwos@mohs.org

Ohio

CCOP - Toledo Community Hospital, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer, MD 419-843-6147

Pennsylvania

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Suresh G. Nair, MD 570-271-6413

South Carolina

CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
James Dewitt Bearden, MD 864-560-6812

South Dakota

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 cincod@siouxvalley.org

Rapid City Regional Hospital, Rapid City, South Dakota, 57709, United States; Recruiting
Larry P. Ebbert, MD 605-341-8704

Wisconsin

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Anthony J. Jaslowski, MD 920-884-3135 ajaslowski@gboncology.com

Study chairs or principal investigators

Scott Okuno, MD, Study Chair, Mayo Clinic Cancer Center

*** POSTED AUGUST 2003 ***