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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started

Description

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.

Official Title

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

Details

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Keywords

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

Eligibility

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)
  • 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
  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Locations

  • 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

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT01085630
Phase
Phase 2
Study Type
Interventional
Last Updated
March 2017