Skip to main content
for people ages 18 years and up
at San Francisco, California and other locations
study started



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.

Official Title

Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy




  • To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.


  • To determine the overall survival of patients treated with this regimen versus observation.
  • To evaluate the frequency of responses in patients treated with this regimen.
  • To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6).

  • Arm I: Patients 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: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.


Malignant Mesothelioma epithelial mesothelioma sarcomatous mesothelioma stage II malignant mesothelioma stage III malignant mesothelioma stage IV malignant mesothelioma Pemetrexed


For people ages 18 years and up

Inclusion Criteria:

  • 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)
  • 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
  • Platelet count>= 100,000/ul
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase[SGOT]) =< 2 x ULN
  • Calculated creatinine clearance>= 45 ml/min
  • Disease not amenable to surgery
  • Must be enrolled on imaging protocol CALGB-580903
  • Complete response, partial response, or stable disease after completion of 4 courses of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or carboplatin
  • Study therapy will begin within 9 weeks following day 1 of cycle 4 of first-line treatment
  • No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium


  • ECOG performance status of 0-1
  • Life expectancy ≥ 12 weeks
  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2 times ULN
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric illness that would prevent the patient from giving informed consent
  • No second malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless curatively treated with no evidence of active disease for ≥ 5 years
  • No medical conditions that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient including, but not limited to,the following:
  • Ongoing or active infection such as HIV positivity
  • Inability to take oral medications
  • Psychiatric illness/social situations that would limit compliance with study requirements


  • See Disease Characteristics
  • Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
  • Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy
  • Prior surgery allowed
  • Prior radiotherapy allowed
  • No concurrent palliative radiotherapy
  • No concurrent hormones or other chemotherapeutic agents except for the following:
  • Steroids for adrenal failure
  • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
  • Intermittent use of dexamethasone as an antiemetic or premedication for pemetrexed disodium


  • Mayo Clinic Scottsdale
    Scottsdale, Arizona, 85259, USA
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    Hartford, Connecticut, 06105, USA
  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    New Britain, Connecticut, 06050, USA
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware, 19958, USA
  • CCOP - Christiana Care Health Services
    Newark, Delaware, 19713, USA
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
    Boise, Idaho, 83706, USA
  • Illinois CancerCare - Bloomington
    Bloomington, Illinois, 61701, USA
  • St. Joseph Medical Center
    Bloomington, Illinois, 61701, USA
  • Illinois CancerCare - Canton
    Canton, Illinois, 61520, USA
  • Illinois CancerCare - Carthage
    Carthage, Illinois, 62321, USA
  • University of Chicago Cancer Research Center
    Chicago, Illinois, 60637, USA
  • Eureka Community Hospital
    Eureka, Illinois, 61530, USA
  • Illinois CancerCare - Eureka
    Eureka, Illinois, 61530, USA
  • Galesburg Clinic, PC
    Galesburg, Illinois, 61401, USA
  • Illinois CancerCare - Havana
    Havana, Illinois, 62644, USA
  • Illinois CancerCare - Kewanee Clinic
    Kewanee, Illinois, 61443, USA
  • La Grange Memorial Hospital
    La Grange, Illinois, 60525, USA
  • Illinois CancerCare - Macomb
    Macomb, Illinois, 61455, USA
  • Illinois CancerCare - Monmouth
    Monmouth, Illinois, 61462, USA
  • OSF Holy Family Medical Center
    Monmouth, Illinois, 61462, USA
  • BroMenn Regional Medical Center
    Normal, Illinois, 61761, USA
  • Community Cancer Center
    Normal, Illinois, 61761, USA
  • Illinois CancerCare - Community Cancer Center
    Normal, Illinois, 61761, USA
  • Community Hospital of Ottawa
    Ottawa, Illinois, 61350, USA
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
    Ottawa, Illinois, 61350, USA
  • Cancer Treatment Center at Pekin Hospital
    Pekin, Illinois, 61554, USA
  • Illinois CancerCare - Pekin
    Pekin, Illinois, 61603, USA
  • Proctor Hospital
    Peoria, Illinois, 61614, USA
  • CCOP - Illinois Oncology Research Association
    Peoria, Illinois, 61615, USA
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
    Peoria, Illinois, 61615, USA
  • Methodist Medical Center of Illinois
    Peoria, Illinois, 61636, USA
  • OSF St. Francis Medical Center
    Peoria, Illinois, 61637, USA
  • Illinois CancerCare - Peru
    Peru, Illinois, 61354, USA
  • Illinois Valley Community Hospital
    Peru, Illinois, 61354, USA
  • Illinois CancerCare - Princeton
    Princeton, Illinois, 61356, USA
  • Illinois CancerCare - Spring Valley
    Spring Valley, Illinois, 61362, USA
  • Elkhart Clinic, LLC
    Elkhart, Indiana, 46514, USA
  • Michiana Hematology-Oncology, PC - Elkhart
    Elkhart, Indiana, 46514, USA
  • Elkhart General Hospital
    Elkhart, Indiana, 46515, USA
  • Howard Community Hospital
    Kokomo, Indiana, 46904, USA
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
    La Porte, Indiana, 46350, USA
  • Michiana Hematology-Oncology, PC - South Bend
    Mishawaka, Indiana, 46545, USA
  • Saint Joseph Regional Medical Center
    Mishawaka, Indiana, 46545, USA
  • Michiana Hematology Oncology PC - Plymouth
    Plymouth, Indiana, 46563, USA
  • CCOP - Northern Indiana CR Consortium
    South Bend, Indiana, 46601, USA
  • Memorial Hospital of South Bend
    South Bend, Indiana, 46601, USA
  • Michiana Hematology Oncology PC - La Porte
    Westville, Indiana, 46391, USA
  • Siouxland Hematology-Oncology Associates, LLP
    Sioux City, Iowa, 51101, USA
  • Mercy Medical Center - Sioux City
    Sioux City, Iowa, 51102, USA
  • St. Luke's Regional Medical Center
    Sioux City, Iowa, 51104, USA
  • Cancer Center of Kansas, PA - Chanute
    Chanute, Kansas, 66720, USA
  • Cancer Center of Kansas, PA - Dodge City
    Dodge City, Kansas, 67801, USA
  • Cancer Center of Kansas, PA - El Dorado
    El Dorado, Kansas, 67042, USA
  • Cancer Center of Kansas - Fort Scott
    Fort Scott, Kansas, 66701, USA
  • Cancer Center of Kansas-Independence
    Independence, Kansas, 67301, USA
  • Cancer Center of Kansas, PA - Kingman
    Kingman, Kansas, 67068, USA
  • Lawrence Memorial Hospital
    Lawrence, Kansas, 66044, USA
  • Cancer Center of Kansas, PA - Liberal
    Liberal, Kansas, 67901, USA
  • Cancer Center of Kansas, PA - McPherson
    McPherson, Kansas, 67460, USA
  • Cancer Center of Kansas, PA - Newton
    Newton, Kansas, 67114, USA
  • Cancer Center of Kansas, PA - Parsons
    Parsons, Kansas, 67357, USA
  • Cancer Center of Kansas, PA - Pratt
    Pratt, Kansas, 67124, USA
  • Cancer Center of Kansas, PA - Salina
    Salina, Kansas, 67401, USA
  • Cancer Center of Kansas, PA - Wellington
    Wellington, Kansas, 67152, USA
  • Associates in Womens Health, PA - North Review
    Wichita, Kansas, 67208, USA
  • Cancer Center of Kansas, PA - Medical Arts Tower
    Wichita, Kansas, 67208, USA
  • Cancer Center of Kansas, PA - Wichita
    Wichita, Kansas, 67214, USA
  • CCOP - Wichita
    Wichita, Kansas, 67214, USA
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas, 67214, USA
  • Cancer Center of Kansas, PA - Winfield
    Winfield, Kansas, 67156, USA
  • Ochsner Health Center - Bluebonnet
    Baton Rouge, Louisiana, 70809, USA
  • Ochsner Health Center - Covington
    Covington, Louisiana, 70433, USA
  • New Orleans Cancer Institute at Memorial Medical Center
    New Orleans, Louisiana, 70115, USA
  • CCOP - Ochsner
    New Orleans, Louisiana, 70121, USA
  • Ochsner Cancer Institute at Ochsner Clinic Foundation
    New Orleans, Louisiana, 70121, USA
  • Greenebaum Cancer Center at University of Maryland Medical Center
    Baltimore, Maryland, 21201, USA
  • Veterans Affairs Medical Center - Baltimore
    Baltimore, Maryland, 21201, USA
  • Union Hospital of Cecil County
    Elkton MD, Maryland, 21921, USA
  • Saint Joseph Mercy Cancer Center
    Ann Arbor, Michigan, 48106, USA
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan, 48106, USA
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
    Dearborn, Michigan, 48123, USA
  • Genesys Hurley Cancer Institute
    Flint, Michigan, 48503, USA
  • Hurley Medical Center
    Flint, Michigan, 48503, USA
  • Genesys Regional Medical Center
    Grand Blanc, Michigan, 48439, USA
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
    Grosse Pointe Woods, Michigan, 48236, USA
  • Foote Memorial Hospital
    Jackson, Michigan, 49201, USA
  • Sparrow Regional Cancer Center
    Lansing, Michigan, 48912, USA
  • St. Mary Mercy Hospital
    Livonia, Michigan, 48154, USA
  • St. Joseph Mercy Oakland
    Pontiac, Michigan, 48341, USA
  • Mercy Regional Cancer Center at Mercy Hospital
    Port Huron, Michigan, 48060, USA
  • Seton Cancer Institute at Saint Mary's - Saginaw
    Saginaw, Michigan, 48601, USA
  • Lakeland Regional Cancer Care Center - St. Joseph
    Saint Joseph, Michigan, 49085, USA
  • Lakeside Cancer Specialists, PLLC
    Saint Joseph, Michigan, 49085, USA
  • St. John Macomb Hospital
    Warren, Michigan, 48093, USA
  • St. Joseph's Medical Center
    Brainerd, Minnesota, 56401, USA
  • Essentia Health - Duluth Clinic
    Duluth, Minnesota, 55805, USA
  • CCOP - Duluth
    Duluth, Minnesota, 55805, USA
  • Miller - Dwan Medical Center
    Duluth, Minnesota, 55805, USA
  • Masonic Cancer Center at University of Minnesota
    Minneapolis, Minnesota, 55455, USA
  • Mayo Clinic Cancer Center
    Rochester, Minnesota, 55905, USA
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, USA
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89106, USA
  • Cancer Institute of New Jersey at Cooper - Voorhees
    Voorhees, New Jersey, 08043, USA
  • CCOP - Hematology-Oncology Associates of Central New York
    East Syracuse, New York, 13057, USA
  • SUNY Upstate Medical University Hospital
    Syracuse, New York, 13210, USA
  • Duke Cancer Institute
    Durham, North Carolina, 27710, USA
  • Wayne Memorial Hospital, Incorporated
    Goldsboro, North Carolina, 27534, USA
  • Kinston Medical Specialists
    Kinston, North Carolina, 28501, USA
  • Iredell Memorial Hospital
    Statesville, North Carolina, 28677, USA
  • Medcenter One Hospital Cancer Care Center
    Bismarck, North Dakota, 58501, USA
  • Mid Dakota Clinic, PC
    Bismarck, North Dakota, 58501, USA
  • St. Alexius Medical Center Cancer Center
    Bismarck, North Dakota, 58502, USA
  • Summa Center for Cancer Care at Akron City Hospital
    Akron, Ohio, 44309, USA
  • Barberton Citizens Hospital
    Barberton, Ohio, 44203, USA
  • Cleveland Clinic Beachwood Family Health and Surgery Center
    Beachwood, Ohio, 44122, USA
  • Cleveland Clinic Cancer Center at Fairview Hospital
    Cleveland, Ohio, 44111, USA
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio, 44195, USA
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    Columbus, Ohio, 43210, USA
  • Cleveland Clinic Cancer Center
    Independence, Ohio, 44131, USA
  • Hillcrest Cancer Center at Hillcrest Hospital
    Mayfield Heights, Ohio, 44124, USA
  • Parma Community General Hospital
    Parma, Ohio, 44129, USA
  • North Coast Cancer Care, Incorporated
    Sandusky, Ohio, 44870, USA
  • Cleveland Clinic Foundation - Strongsville
    Strongsville, Ohio, 44136, USA
  • Cleveland Clinic - Wooster
    Wooster, Ohio, 44691, USA
  • Clackamas Radiation Oncology Center
    Clackamas, Oregon, 97015, USA
  • Providence Milwaukie Hospital
    Milwaukie, Oregon, 97222, USA
  • Providence Newberg Medical Center
    Newberg, Oregon, 97132, USA
  • Willamette Falls Hospital
    Oregon City, Oregon, 97045, USA
  • Providence Cancer Center at Providence Portland Medical Center
    Portland, Oregon, 97213, USA
  • CCOP - Columbia River Oncology Program
    Portland, Oregon, 97225, USA
  • Providence St. Vincent Medical Center
    Portland, Oregon, 97225, USA
  • Rosenfeld Cancer Center at Abington Memorial Hospital
    Abington, Pennsylvania, 19001, USA
  • Geisinger Cancer Institute at Geisinger Health
    Danville, Pennsylvania, 17822, USA
  • Geisinger Hazleton Cancer Center
    Hazleton, Pennsylvania, 18201, USA
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania, 19104, USA
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania, 19111, USA
  • UPMC Cancer Centers
    Pittsburgh, Pennsylvania, 15232, USA
  • Geisinger Medical Group - Scenery Park
    State College, Pennsylvania, 16801, USA
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    Wilkes-Barre, Pennsylvania, 18711, USA
  • Roper St. Francis Cancer Center at Roper Hospital
    Charleston, South Carolina, 29401, USA
  • Danville Regional Medical Center
    Danville, Virginia, 24541, USA
  • Southwest Washington Medical Center Cancer Center
    Vancouver, Washington, 98664, USA
  • Northwest Cancer Specialists at Vancouver Cancer Center
    Vancouver, Washington, 98684, USA
  • Gundersen Lutheran Center for Cancer and Blood
    La Crosse, Wisconsin, 54601, USA


in progress, not accepting new patients
Start Date
Alliance for Clinical Trials in Oncology
Phase 2
Study Type
Last Updated
March 2017