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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
21 days
Yes
Anne Tsao
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-02015
NCT01064648
March 2010
Name | Location |
---|---|
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Grandview Hospital | Dayton, Ohio 45405 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Wayne Hospital | Greenville, Ohio 45331 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Memorial Medical Center | Springfield, Illinois 62781 |
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee 37662 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Wayne State University | Detroit, Michigan 48202 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Kaiser Permanente | Sacramento, California |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Southern California | Los Angeles, California 90033 |
Castle Medical Center | Kailua, Hawaii 96734 |
Highlands Oncology Group-Bentonville | Bentonville, Arkansas 72712 |
Kaiser Permanente, Fremont | Fremont, California 94538 |
Kaiser Permanente, Hayward | Hayward, California 94545 |
Kaiser Permanente-Oakland | Oakland, California 94611 |
Kaiser Permanente-Redwood City | Redwood City, California 94063 |
Kaiser Permanente-Richmond | Richmond, California 94801 |
Kaiser Permanente-Roseville | Roseville, California 95661 |
Kaiser Permanente-South Sacramento | Sacramento, California 95823 |
Kaiser Permanente - Sacramento | Sacramento, California 95825 |
Kaiser Permanente-San Francisco | San Francisco, California 94115 |
Kaiser Permanente-Santa Teresa-San Jose | San Jose, California 95119 |
Kaiser Permanente-San Rafael | San Rafael, California 94903 |
Kaiser Permanente-Santa Rosa | Santa Rosa, California 95403 |
Kaiser Permanente-South San Francisco | South San Francisco, California 94080 |
Kaiser Permanente-Stockton | Stockton, California 95210 |
Kaiser Permanente-Vallejo | Vallejo, California 94589 |
Kaiser Permanente-Walnut Creek | Walnut Creek, California 94596 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Greenville CCOP | Greenville, South Carolina 29615 |
Greenville Memorial Hospital | Greenville, South Carolina 29605 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas-Greer Medical Oncology | Greer, South Carolina 29650 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Kuakini Medical Center | Honolulu, Hawaii 96817 |
Kaiser Permanente-Deer Valley Medical Center | Antioch, California 94531 |
Kaiser Permanente Medical Center-Vacaville | Vacaville, California 95688 |
Kaiser Permanente Moanalua Medical Center | Honolulu, Hawaii 96819 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center-Main Campus | Burien, Washington 98166 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Swedish Cancer Institute-Issaquah | Issaquah, Washington 98029 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Southwest Oncology Group (SWOG) Research Base | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
OnCare Hawaii-Liliha | Honolulu, Hawaii 96817-3169 |
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Swedish Medical Center-Edmonds | Edmonds, Washington 98026 |
Kaiser Permanente-Modesto | Modesto, California 95356 |