Trial record 1 of 1 for:    S0905
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Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Verified December 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01064648
First received: February 5, 2010
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.


Condition Intervention Phase
Advanced Malignant Mesothelioma
Epithelial Mesothelioma
Recurrent Malignant Mesothelioma
Sarcomatous Mesothelioma
Drug: pemetrexed disodium
Drug: cisplatin
Drug: cediranib maleate
Other: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination With Cisplatin and Pemetrexed in Chemonaive Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose determined if the dose-limiting toxicity rate is less than or equal to 33% according to NCI CTCAE version 4.0 (Phase I) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Progression-free survival (Phase II) [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    A stratified log-rank test at the 0.1 level will be used.


Secondary Outcome Measures:
  • Overall survival (Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    A stratified log-rank test will be used to compare overall survival.

  • Response (Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    A stratified chi-square test will be used to compare response and toxicity between the two arms.

  • Toxicity assessed using NCI CTCAE version 4.0 (Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    A stratified chi-square test will be used to compare response and toxicity between the two arms.


Estimated Enrollment: 116
Study Start Date: March 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (phase II)
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and oral cediranib maleate once daily at the maximum tolerated dose determined in phase I on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral cediranib maleate alone once daily in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Given IV
Other Names:
  • ALIMTA
  • LY231514
  • MTA
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: cediranib maleate
Given orally
Other Names:
  • AZD2171
  • Recentin
Active Comparator: Arm II (phase II)
Patients receive pemetrexed disodium and cisplatin as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral placebo alone once daily in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Given IV
Other Names:
  • ALIMTA
  • LY231514
  • MTA
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Other: placebo
Given orally
Other Name: PLCB

Detailed Description:

OBJECTIVES:

I. To establish the maximum tolerated dose and the recommended phase II dose of cediranib maleate in combination with pemetrexed disodium and cisplatin in patients with malignant pleural mesothelioma. (Phase I) II. To compare the progression-free survival of patients treated with pemetrexed disodium and cisplatin with vs without cediranib maleate. (Phase II) III. To compare the overall survival of patients treated with these regimens. (Phase II) IV. To assess the safety and toxicity profile of these regimens. V. To assess the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (responsive or stable disease) using RECIST criteria and modified RECIST criteria for pleural tumors in a subset of patients with measurable disease. (Phase II) VI. To assess the rate of agreement between local and central pathology review of mesothelioma and its histologic subtypes. (Phase II) VII. To collect specimens for banking for use in future research studies. (Phase II)

OUTLINE: This is a multicenter, phase I dose-escalation study of cediranib maleate followed by a phase II randomized study. Patients enrolled in the phase II portion of the study are stratified according to Zubrod performance status (0-1 vs 2) and histologic subtype (epithelioid vs biphasic/sarcomatoid).

PHASE I: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and oral cediranib maleate once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral cediranib maleate alone once daily in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and oral cediranib maleate once daily at the maximum tolerated dose determined in phase I on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral cediranib maleate alone once daily in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pemetrexed disodium and cisplatin as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral placebo alone once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant pleural mesothelioma

    • Not planning to undergo surgical resection
  • Patients must have measurable or non-measurable disease by both RECIST and modified RECIST criteria for pleural tumors as documented by CT scan; examinations for assessment of measurable disease must have been completed within 28 days prior to registration; examinations for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the RECIST 1.1 and Modified RECIST Baseline Tumor Assessment Form
  • Zubrod performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL (transfusion allowed)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • Proteinuria ≤ +1 on 2 consecutive dipsticks taken ≥ 7 days apart

    • Repeat urinalysis not required provided first urinalysis shows no protein
  • Not pregnant or nursing
  • Fertile patients must agree to use effective contraception
  • Must be able to swallow oral medications
  • No mean QTc > 500 msec (with Bazett correction) by ECG or other significant ECG abnormality
  • No NYHA class III-IV congestive heart failure
  • No clinically significant hemoptysis, defined as > 1 tablespoon of bright red blood, within the past year
  • No known HIV infection
  • No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission.
  • No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer
  • No prior systemic therapy (chemotherapy or other biological therapy) for unresectable malignant pleural mesothelioma

    • Prior systemicchemotherapy or biologic therapy as neoadjuvant or adjuvant therapy allowed provided disease has recurred and systemic therapy was completed > 6 months before study entry
  • No prior therapy with any of the study drugs
  • At least 28 days since prior surgery (e.g., pleurectomy, pleurodeses, thoracic or other major surgeries) and recovered
  • At least 28 days since prior radiotherapy and recovered
  • No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
  • No concurrent drugs or biologics with proarrhythmic potential
  • No concurrent major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064648

  Hide Study Locations
Locations
United States, Arkansas
Highlands Oncology Group-Rogers Recruiting
Rogers, Arkansas, United States, 72758
Contact: Joseph T. Beck    800-381-6939      
Principal Investigator: Joseph T. Beck         
United States, California
Kaiser Permanente-Deer Valley Medical Center Recruiting
Antioch, California, United States, 94531
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente, Fremont Recruiting
Fremont, California, United States, 94538
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente Recruiting
Fresno, California, United States, 93720
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente, Hayward Recruiting
Hayward, California, United States, 94545
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
University of Southern California Active, not recruiting
Los Angeles, California, United States, 90033-0804
Los Angeles County-USC Medical Center Active, not recruiting
Los Angeles, California, United States, 90033
Kaiser Permanente-Modesto Recruiting
Modesto, California, United States, 95356
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
University of California Medical Center At Irvine-Orange Campus Recruiting
Orange, California, United States, 92868
Contact: Sai-Hong I. Ou    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Sai-Hong I. Ou         
Kaiser Permanente-Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Richmond Recruiting
Richmond, California, United States, 94801
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-South Sacramento Recruiting
Sacramento, California, United States, 95823
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente - Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Karen L. Kelly    916-734-3089      
Principal Investigator: Karen L. Kelly         
Kaiser Permanente-San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Santa Teresa-San Jose Recruiting
San Jose, California, United States, 95119
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-San Rafael Recruiting
San Rafael, California, United States, 94903
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Santa Rosa Recruiting
Santa Rosa, California, United States, 95403
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Stockton Recruiting
Stockton, California, United States, 95210
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente Medical Center-Vacaville Recruiting
Vacaville, California, United States, 95688
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
United States, Connecticut
Saint Francis Hospital and Medical Center Active, not recruiting
Hartford, Connecticut, United States, 06105
United States, Florida
M D Anderson Cancer Center- Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Tirrell T. Johnson    321-841-7246      
Principal Investigator: Tirrell T. Johnson         
United States, Georgia
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Charles H. Nash    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Charles H. Nash         
United States, Hawaii
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kapiolani Medical Center at Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kaiser Permanente Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817-3169
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kuakini Medical Center Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Oncare Hawaii Inc-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Wilcox Memorial Hospital and Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
United States, Idaho
Saint Alphonsus Regional Medical Center Active, not recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Indiana
Saint Francis Hospital and Health Centers Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross    765-983-3000      
Principal Investigator: Howard M. Gross         
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Reid Hospital and Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Susanne M. Arnold    859-257-3379      
Principal Investigator: Susanne M. Arnold         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Gregory P. Kalemkerian    800-865-1125      
Principal Investigator: Gregory P. Kalemkerian         
Saint Joseph Mercy Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program Active, not recruiting
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital Active, not recruiting
Dearborn, Michigan, United States, 48124
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert A. Chapman    313-916-1784      
Principal Investigator: Robert A. Chapman         
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Shirish M. Gadgeel    313-576-9363      
Principal Investigator: Shirish M. Gadgeel         
Saint John Hospital and Medical Center Active, not recruiting
Detroit, Michigan, United States, 48236
Genesys Hurley Cancer Institute Active, not recruiting
Flint, Michigan, United States, 48503
Hurley Medical Center Active, not recruiting
Flint, Michigan, United States, 48502
Genesys Regional Medical Center-West Flint Campus Recruiting
Flint, Michigan, United States, 48532
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Allegiance Health Active, not recruiting
Jackson, Michigan, United States, 49201
Sparrow Hospital Active, not recruiting
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital Active, not recruiting
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland Active, not recruiting
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron Active, not recruiting
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan Active, not recruiting
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital Active, not recruiting
Warren, Michigan, United States, 48093
United States, Mississippi
Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson    228-809-5292      
Principal Investigator: James E. Clarkson         
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Montana
Saint Vincent Healthcare Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Montana Cancer Consortium CCOP Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Hematology-Oncology Centers of the Northern Rockies PC Active, not recruiting
Billings, Montana, United States, 59102
Bozeman Deaconess Cancer Center Active, not recruiting
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint James Community Hospital and Cancer Treatment Center Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Great Falls Clinic Active, not recruiting
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Glacier Oncology PLLC Terminated
Kalispell, Montana, United States, 59901
Montana Cancer Specialists Active, not recruiting
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, North Carolina
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Justin P. Favaro    704-384-5369      
Principal Investigator: Justin P. Favaro         
Margaret R Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford    828-696-4716      
Principal Investigator: James E. Radford         
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm    704-873-5661      
Principal Investigator: Ruby A. Grimm         
United States, Ohio
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Dayton CCOP Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Good Samaritan Hospital - Dayton Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross    765-983-3000      
Principal Investigator: Howard M. Gross         
Samaritan North Health Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross    765-983-3000      
Principal Investigator: Howard M. Gross         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Blanchard Valley Hospital Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Atrium Medical Center-Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross    317-783-8918      
Principal Investigator: Howard M. Gross         
Genesis HealthCare System Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Milwaukie Hospital Recruiting
Milwaukie, Oregon, United States, 97222
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Willamette Falls Medical Center Recruiting
Oregon City, Oregon, United States, 97045
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Columbia River Oncology Program Recruiting
Portland, Oregon, United States, 97225
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
United States, South Carolina
Greenville CCOP Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Cancer Centers of the Carolinas - Grove Commons Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Cancer Centers of the Carolinas - Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Cancer Centers of the Carolinas-Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Cancer Centers of the Carolinas - Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
United States, Tennessee
Wellmont Holston Valley Hospital and Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Asheesh Shipstone    423-578-8538      
Principal Investigator: Asheesh Shipstone         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anne S. Tsao    713-792-3245      
Principal Investigator: Anne S. Tsao         
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Southwest Oncology Group (SWOG) Research Base Recruiting
San Antonio, Texas, United States, 78245
Contact: Anne S. Tsao       astsao@mdanderson.org   
Principal Investigator: Anne S. Tsao         
Southwest Oncology Group Recruiting
San Antonio, Texas, United States, 78245
Contact: Anne S. Tsao       astsao@mdanderson.org   
Principal Investigator: Anne S. Tsao         
United States, Virginia
Danville Regional Medical Center Recruiting
Danville, Virginia, United States, 24541
Contact: Timothy W. Brotherton    434-793-0044      
Principal Investigator: Timothy W. Brotherton         
United States, Washington
Cancer Care Center at Island Hospital Recruiting
Anacortes, Washington, United States, 98221
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
PeaceHealth Saint Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Harrison Bremerton Hematology and Oncology Recruiting
Bremerton, Washington, United States, 98310
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Highline Medical Center-Main Campus Recruiting
Burien, Washington, United States, 98166
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Swedish Medical Center-Edmonds Recruiting
Edmonds, Washington, United States, 98026
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Swedish Cancer Institute-Issaquah Recruiting
Issaquah, Washington, United States, 98029
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Columbia Basin Hematology and Oncology PLLC Recruiting
Kennewick, Washington, United States, 99336
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Skagit Valley Hospital Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Harrison Poulsbo Hematology and Oncology Recruiting
Poulsbo, Washington, United States, 98370
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Minor and James Medical PLLC Recruiting
Seattle, Washington, United States, 98104
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Swedish Medical Center-Ballard Campus Recruiting
Seattle, Washington, United States, 98107
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Swedish Medical Center-First Hill Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Group Health Cooperative Recruiting
Seattle, Washington, United States, 98112
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
The Polyclinic Active, not recruiting
Seattle, Washington, United States, 98122
United General Hospital Recruiting
Sedro-Woolley, Washington, United States, 98284
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Evergreen Hematology and Oncology PS Recruiting
Spokane, Washington, United States, 99218
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
PeaceHealth Southwest Medical Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Northwest Cancer Specialists Recruiting
Vancouver, Washington, United States, 98684
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Contact: Gary E. Goodman    206-386-2323    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman         
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Welch Cancer Center Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Sponsors and Collaborators
Investigators
Principal Investigator: Anne Tsao Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01064648     History of Changes
Other Study ID Numbers: NCI-2011-02015, NCI-2011-02015, CDR0000665415, S0905, S0905, U10CA032102
Study First Received: February 5, 2010
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Cisplatin
Maleic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014