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Clinical Trials (PDQ®)

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITissue collection/Repository, TreatmentActive18 and overNCINCI-2011-02015
CDR0000665415, S0905, U10CA032102, SWOG-S0905, NCT01064648

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Anne TsaoPrincipal Investigator

Trial Sites

U.S.A.
Arkansas
  Rogers
 Highlands Oncology Group - Bentonville
 Joseph Thaddeus Beck Ph: 800-381-6939
California
  Antioch
 Kaiser Permanente - Deer Valley
 Louis Fehrenbacher Ph: 626-564-3455
  Fremont
 Kaiser Permanente - Fremont
 Louis Fehrenbacher Ph: 626-564-3455
  Fresno
 Kaiser Permanente Fresno Medical Center
 Louis Fehrenbacher Ph: 626-564-3455
  Modesto
 Kaiser Permanente-Modesto
 Louis Fehrenbacher Ph: 626-564-3455
  Oakland
 Kaiser Permanente-Oakland
 Louis Fehrenbacher Ph: 626-564-3455
  Redwood City
 Kaiser Permanente Medical Center - Redwood City
 Louis Fehrenbacher Ph: 626-564-3455
  Richmond
 Kaiser Permanente Medical Center - Richmond
 Louis Fehrenbacher Ph: 626-564-3455
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Louis Fehrenbacher Ph: 626-564-3455
 South Sacramento Kaiser-Permanente Medical Center
 Louis Fehrenbacher Ph: 626-564-3455
 University of California Davis Cancer Center
 Karen Kelly Ph: 916-734-3089
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Louis Fehrenbacher Ph: 626-564-3455
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Louis Fehrenbacher Ph: 626-564-3455
  San Leandro
 Kaiser Permanente Medical Center - Hayward
 Louis Fehrenbacher Ph: 626-564-3455
  San Rafael
 Kaiser Foundation Hospital - San Rafael
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Rosa
 Kaiser Permanente Medical Center - Santa Rosa
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Louis Fehrenbacher Ph: 626-564-3455
  Stockton
 Kaiser Permanente Medical Facility - Stockton
 Louis Fehrenbacher Ph: 626-564-3455
  Vacaville
 Kaiser Permanente Medical Center - Vacaville
 Louis Fehrenbacher Ph: 626-564-3455
  Vallejo
 Kaiser Permanente Medical Center - Vallejo
 Louis Fehrenbacher Ph: 626-564-3455
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Louis Fehrenbacher Ph: 626-564-3455
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
Florida
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Tirrell T Johnson Ph: 321-841-7246
  Email: CancerClinicalTrials@orlandohealth.com
Hawaii
  Honolulu
 Kaiser Permanente - Moanalua Medical Center and Clinic
 Louis Fehrenbacher Ph: 626-564-3455
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 CCOP - Central Illinois
 Anne S Tsao Ph: 713-792-6363
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Susanne M. Arnold Ph: 859-257-3379
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
 University of Michigan Comprehensive Cancer Center
 Anne S Tsao Ph: 713-792-6363
 Gregory P. Kalemkerian Ph: 800-865-1125
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
 Wayne State University
 Shirish M. Gadgeel Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-4673
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-4673
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Mississippi
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
North Carolina
  Charlotte
 Carolina Surgical Clinic of Charlotte, PA
 Justin P Favaro Ph: 704-384-5369
 Oncology Specialists of Charlotte
 Justin P Favaro Ph: 704-384-5369
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
 Southern Oncology Specialists
 Justin P Favaro Ph: 704-384-5369
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Hendersonville Hematology and Oncology
 James E. Radford Ph: 828-696-4716
  Huntersville
 Southern Oncology Specialists
 Justin P Favaro Ph: 704-384-5369
  Matthews
 Matthews Hematology Oncology Associates
 Justin P Favaro Ph: 704-384-5369
  Mooresville
 Lake Norman Hematology Oncology Specialists
 Justin P Favaro Ph: 704-384-5369
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
  Winston-Salem
 CCOP - Southeast Cancer Control Consortium
 Anne S Tsao Ph: 713-792-6363
Ohio
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Columbus
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 800-446-5532
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
 Southwest Oncology Group
 Anne S Tsao
  Email: astsao@mdanderson.org
South Carolina
  Easley
 Cancer Centers of the Carolinas - Easley
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greenville
 Cancer Centers of the Carolinas - Andrews
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
Tennessee
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Asheesh Shipstone Ph: 423-578-8538
 Kingsport Hematology-Oncology Associates
 Asheesh Shipstone Ph: 423-578-8538
Texas
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Anne S Tsao Ph: 713-792-3245
  San Antonio
 Southwest Oncology Group
 Anne S Tsao
  Email: astsao@mdanderson.org
Virginia
  Danville
 Danville Hematology and Oncology, Incorporated
 Qiwei W Gai Ph: 434-793-0044
 Danville Regional Medical Center
 Timothy W. Brotherton Ph: 434-793-0044
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone Ph: 423-578-8538
Washington
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01064648
ClinicalTrials.gov processed this data on December 15, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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