Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma
Mesothelioma
About this trial
This is an interventional treatment trial for Mesothelioma focused on measuring advanced malignant mesothelioma, recurrent malignant mesothelioma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed advanced mesothelioma of the pleura Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization. Patients with pleural rinds not measurable by RECIST were eligible if disease was evaluable within 4 weeks of randomization using mesothelioma response criteria May have undergone pleurodesis. If pleurodesis was performed, there must have been at least a 2-week delay before Pemetrexed administration. A CT must have been performed after 2 weeks after pleurodesis to serve as the baseline scan. ECOG Performance Status of 0 or 1 Normal organ and marrow function, as defined by: Absolute neutrophil count ≥ 1,500/ul Platelet count ≥ 100,000/ul Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) Albumin ≥ 2.5 g/dL Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL Age 18 years and over Able to take folic acid and cyanocobalamin (vitamin B12) Willing and able to take dexamethasone Women of childbearing potential and sexually active men were required to use contraception during and for the first 3 months after the study Exclusion Criteria A candidate for curative surgery Prior radiation therapy to the target lesion, unless the lesion was clearly progressing per RECIST criteria after prior radiation and the interval between the most recent radiation therapy and enrollment was at least 4 weeks Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or immunomodulators were not permitted, unless given for the purpose of pleurodesis. Active infection or serious concomitant systemic disorder Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence. Treatment with an investigational agent within 4 weeks before enrollment Known or suspected brain metastases Women must not be pregnant or breastfeeding Obviously malnourished or with a weight loss of greater than 10% in the preceding 6 weeks Aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone)
Sites / Locations
- Eastern Connecticut Hematology and Oncology Associates
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Mayo Clinic - Jacksonville
- Winship Cancer Institute of Emory University
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Indiana University Melvin and Bren Simon Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- William N. Wishard Memorial Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital Cancer Program at Union Hospital
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- HealthEast Cancer Care at St. Joseph's Hospital
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Aultman Cancer Center at Aultman Hospital
- Case Comprehensive Cancer Center
- St. Rita's Medical Center
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Fox Chase Cancer Center - Philadelphia
- Albert Einstein Cancer Center
- Mount Nittany Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pemetrexed/Carboplatin
Pemetrexed/Gemcitabine
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to area under the curve (AUC) 5 IV over 30 minutes on day 1 of a 21-day cycle.
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.