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NCT00101283 Clinical Trial

Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma

Mesothelioma Clinical Trial

Official title:
Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00101283
Other study ID # CDR0000401795
Secondary ID U10CA021115E1B03
Status Completed
Phase Phase 2
First received
Last updated
Start date February 23, 2006
Est. completion date May 2011

Study information
Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma. PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.

Description:

OBJECTIVES: Primary - Estimate the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin. Secondary - Assess the toxic effects of these regimens in these patients. - Estimate survival time in patients treated with these regimens. - Correlate smoking status with outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. While randomized, the study is not a comparative study. Rather, outcomes on each arm will be compared to a historical control rate from previous studies. Randomization allows simultaneous testing of two experimental arms. - Arm I: Patients receive intravenous (IV) pemetrexed disodium over 10 minutes and carboplatin IV over 30 minutes on day 1. - Arm II: Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion of chemotherapy, all patients receive oral folic acid once daily and cyanocobalamin (vitamin B12) intramuscularly every 9 weeks. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 32-60 patients (16-30 per treatment arm) will be accrued for this study within 12.8-27.0 months.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date May 2011
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• pemetrexed disodium
500 mg/m2 IV over 10 minutes on day 1 of a 21-day cycle
• gemcitabine hydrochloride
1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle
• carboplatin
Given by IV over 30 minutes at an area under the curve (AUC) of 5 on day 1 of a 21-day cycle

Locations
Country Name City State
United States Summa Center for Cancer Care at Akron City Hospital Akron Ohio
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States McFarland Clinic, PC Ames Iowa
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Rush-Copley Cancer Care Center Aurora Illinois
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States St. Joseph Medical Center Bloomington Illinois
United States Fairview Ridges Hospital Burnsville Minnesota
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Graham Hospital Canton Illinois
United States Memorial Hospital Carthage Illinois
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Case Comprehensive Cancer Center Cleveland Ohio
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States Fairview Southdale Hospital Edina Minnesota
United States Elkhart General Hospital Elkhart Indiana
United States Union Hospital Cancer Program at Union Hospital Elkton Maryland
United States Eureka Community Hospital Eureka Illinois
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Galesburg Clinic, PC Galesburg Illinois
United States Galesburg Cottage Hospital Galesburg Illinois
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Mason District Hospital Havana Illinois
United States Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania
United States Hopedale Medical Complex Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis Indianapolis Indiana
United States William N. Wishard Memorial Hospital Indianapolis Indiana
United States Foote Memorial Hospital Jackson Michigan
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kewanee Hospital Kewanee Illinois
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Sparrow Regional Cancer Center Lansing Michigan
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Lewistown Hospital Lewistown Pennsylvania
United States St. Rita's Medical Center Lima Ohio
United States Meeker County Memorial Hospital Litchfield Minnesota
United States McDonough District Hospital Macomb Illinois
United States University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois
United States Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey
United States CCOP - Christiana Care Health Services Newark Delaware
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania
United States Perry Memorial Hospital Princeton Illinois
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States HealthEast Cancer Care at St. Joseph's Hospital Saint Paul Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States St. Margaret's Hospital Spring Valley Illinois
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States Mount Nittany Medical Center State College Pennsylvania
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States HealthEast Cancer Care at Woodwinds Health Campus Woodbury Minnesota
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota

Sponsors (3)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI), North Central Cancer Treatment Group

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Overall Response by RECIST Criteria (Version 1.0) Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression. Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression
Secondary Overall Survival Time from randomization to death. Patients alive at last follow-up were censored. Assessed every 3 months for 2 years, then every 6 months for 1 year
Secondary Progression-Free Survival Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Assessed every 3 months for 2 years, then every 6 months for 1 year
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