Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma
NCT ID: NCT00017186
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2001-07-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
gemcitabine + epirubicin
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.
epirubicin hydrochloride
gemcitabine hydrochloride
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
epirubicin hydrochloride
gemcitabine hydrochloride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Okuno, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444.
Okuno SH, Delaune R, Sloan JA, Foster NR, Maurer MJ, Aubry MC, Rowland KM Jr, Soori GS, Nikcevich DA, Kardinal CG, Northfelt DW, Adjei AA; North Central Cancer Treatment Group. A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma: a North Central Cancer Treatment Study, N0021. Cancer. 2008 Apr 15;112(8):1772-9. doi: 10.1002/cncr.23313.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCCTG-N0021
Identifier Type: -
Identifier Source: secondary_id
CDR0000068659
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N0021
Identifier Type: -
Identifier Source: org_study_id