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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Mesothelioma

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant pleural mesothelioma meeting 1 of the following
cell types:

- Epithelial

- Sarcomatoid

- Mixed type

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Arkadiusz Dudek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

Unspecified

Study ID:

CDR0000667496

NCT ID:

NCT01085630

Start Date:

April 2010

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - OchsnerNew Orleans, Louisiana  70121
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
SUNY Upstate Medical University HospitalSyracuse, New York  13210
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Parma Community General HospitalParma, Ohio  44129
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
St. Joseph Medical CenterBloomington, Illinois  61701
Eureka Community HospitalEureka, Illinois  61530
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Iredell Memorial HospitalStatesville, North Carolina  28677
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Cleveland Clinic - WoosterWooster, Ohio  44691
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Danville Regional Medical CenterDanville, Virginia  24541
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Ochsner Health Center - BluebonnetBaton Rouge, Louisiana  70809
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Duke Cancer InstituteDurham, North Carolina  27710
Kinston Medical SpecialistsKinston, North Carolina  28501
La Grange Memorial HospitalLa Grange, Illinois  60525
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
OSF Holy Family Medical CenterMonmouth, Illinois  61462
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Ochsner Health Center - CovingtonCovington, Louisiana  70433
New Orleans Cancer Institute at Memorial Medical CenterNew Orleans, Louisiana  70115
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684
Cleveland Clinic Beachwood Family Health and Surgery CenterBeachwood, Ohio  44122
Cleveland Clinic Foundation - StrongsvilleStrongsville, Ohio  44136
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Willamette Falls HospitalOregon City, Oregon  97045
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
Essentia Health - Duluth ClinicDuluth, Minnesota  55805-1983