Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
4 other identifiers
interventional
72
1 country
145
Brief Summary
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
Longer than P75 for phase_2
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedAugust 18, 2021
August 1, 2021
7.3 years
March 11, 2010
February 5, 2019
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Baseline up to 3 years
Secondary Outcomes (3)
Overall Survival
Baseline up to 3 years
Response Rate
Up to 3 years
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
Baseline up to 3 years
Study Arms (2)
Arm I
EXPERIMENTALPatients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II
ACTIVE COMPARATORPatients undergo observation until disease progression.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
- Epithelial
- Sarcomatoid
- Mixed type
- Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection
- Prior treatment
- Currently receiving first-line treatment with pemetrexed + platinum; patients are to be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day of cycle 4 of first line therapy
- Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
- Prior surgical treatment is allowed
- Prior radiation therapy is allowed
- Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
- RANDOMIZATION ELIGIBILITY CRITERIA
- Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Granulocytes \>= 1,500/ul
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, 06050, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare - Canton
Canton, Illinois, 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois, 62321, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Havana
Havana, Illinois, 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443, United States
La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
Illinois CancerCare - Macomb
Macomb, Illinois, 61455, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462, United States
OSF Holy Family Medical Center
Monmouth, Illinois, 61462, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Illinois CancerCare - Pekin
Pekin, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare - Peru
Peru, Illinois, 61354, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois, 61356, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Ochsner Health Center - Bluebonnet
Baton Rouge, Louisiana, 70809, United States
Ochsner Health Center - Covington
Covington, Louisiana, 70433, United States
New Orleans Cancer Institute at Memorial Medical Center
New Orleans, Louisiana, 70115, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
St. Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health - Duluth Clinic
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Kinston Medical Specialists
Kinston, North Carolina, 28501, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, 44122, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240, United States
Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Parma Community General Hospital
Parma, Ohio, 44129, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, 44136, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Willamette Falls Hospital
Oregon City, Oregon, 97045, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, 29401, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98664, United States
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, 98684, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arkadiusz Z. Dudek M.D., Ph.D.
- Organization
- HealthPartners Cancer Care Center
Study Officials
- STUDY CHAIR
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 12, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2017
Study Completion
April 1, 2021
Last Updated
August 18, 2021
Results First Posted
March 5, 2019
Record last verified: 2021-08