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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 Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
CCOP - Ochsner New Orleans, Louisiana  70121
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
SUNY Upstate Medical University Hospital Syracuse, New York  13210
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Parma Community General Hospital Parma, Ohio  44129
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
UPMC Cancer Centers Pittsburgh, Pennsylvania  15232
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
St. Joseph Medical Center Bloomington, Illinois  61701
Eureka Community Hospital Eureka, Illinois  61530
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
St. Joseph's Medical Center Brainerd, Minnesota  56401
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Iredell Memorial Hospital Statesville, North Carolina  28677
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Cleveland Clinic - Wooster Wooster, Ohio  44691
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Danville Regional Medical Center Danville, Virginia  24541
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Ochsner Health Center - Bluebonnet Baton Rouge, Louisiana  70809
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Union Hospital of Cecil County Elkton MD, Maryland  21921
Duke Cancer Institute Durham, North Carolina  27710
Kinston Medical Specialists Kinston, North Carolina  28501
La Grange Memorial Hospital La Grange, Illinois  60525
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Galesburg Clinic, PC Galesburg, Illinois  61401
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
OSF Holy Family Medical Center Monmouth, Illinois  61462
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Ochsner Health Center - Covington Covington, Louisiana  70433
New Orleans Cancer Institute at Memorial Medical Center New Orleans, Louisiana  70115
Northwest Cancer Specialists at Vancouver Cancer Center Vancouver, Washington  98684
Cleveland Clinic Beachwood Family Health and Surgery Center Beachwood, Ohio  44122
Cleveland Clinic Foundation - Strongsville Strongsville, Ohio  44136
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
Essentia Health - Duluth Clinic Duluth, Minnesota  55805-1983