Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
NCT ID: NCT01085630
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2010-04-30
2021-04-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
pemetrexed disodium
Given IV
Arm II
Patients undergo observation until disease progression.
clinical observation
Interventions
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pemetrexed disodium
Given IV
clinical observation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Arkadiusz Dudek, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Illinois CancerCare - Havana
Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
Illinois CancerCare - Macomb
Macomb, Illinois, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States
OSF Holy Family Medical Center
Monmouth, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare - Pekin
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare - Peru
Peru, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Illinois CancerCare - Princeton
Princeton, Illinois, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Ochsner Health Center - Bluebonnet
Baton Rouge, Louisiana, United States
Ochsner Health Center - Covington
Covington, Louisiana, United States
New Orleans Cancer Institute at Memorial Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
St. Joseph's Medical Center
Brainerd, Minnesota, United States
Essentia Health - Duluth Clinic
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Cleveland Clinic Cancer Center
Independence, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Parma Community General Hospital
Parma, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Willamette Falls Hospital
Oregon City, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
Danville Regional Medical Center
Danville, Virginia, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CALGB-30901
Identifier Type: -
Identifier Source: secondary_id
CDR0000667496
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-30901
Identifier Type: -
Identifier Source: org_study_id
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