Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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) (completed as of 9-9-2011)
2. To compare the progression-free survival of patients treated with pemetrexed disodium and cisplatin with vs without cediranib maleate. (Phase II)
3. To compare the overall survival of patients treated with these regimens. (Phase II)
4. To assess the safety and toxicity profile of these regimens.
5. 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)
6. To assess the rate of agreement between local and central pathology review of mesothelioma and its histologic subtypes. (Phase II)
7. To collect specimens for banking for use in future research studies. (Phase II)

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed malignant pleural mesothelioma
  • Not planning to undergo surgical resection

• Measurable or non-measurable disease by RECIST or modified RECIST criteria for pleural tumors as documented by CT scan

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior systemic therapy (chemotherapy or other biological therapy) for unresectable malignant pleural mesothelioma
  • Prior systemic chemotherapy 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 cediranib
• 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
• No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer

Patient Characteristics:

• Zubrod performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

Maximum-tolerated dose of cediranib maleate (Phase I)
Safety and toxicity (Phase I)
Progression-free survival (Phase II)

Overall survival (Phase II)
Response rate (confirmed and unconfirmed, complete and partial responses) (Phase II)
Disease control rate (responsive or stable disease) (Phase II)
Safety and toxicity profile (Phase II)
Rate of agreement between local and central pathology review of mesothelioma and its histologic subtypes (Phase II)

Outline

This is a multicenter, phase I dose-escalation study of cediranib maleate (completed as of 9-9-2011) 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. (completed as of 9-9-2011)

• 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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Anne Tsao, MD, Principal investigator		Ph: 713-792-6363; 800-392-1611

U.S.A.
California
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip Stella, MD	Ph:  734-712-1000
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Charles Nash, MD	Ph:  770-297-5700
Hawaii
	Aiea
	Kapiolani Medical Center at Pali Momi
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Oncare Hawaii, Incorporated - Pali Momi
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph:  808-586-2979
	Kapiolani Medical Center for Women and Children
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Kuakini Medical Center
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	OnCare Hawaii, Incorporated - Kuakini
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	OnCare Hawaii, Incorporated - Lusitana
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Queen's Cancer Institute at Queen's Medical Center
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Straub Clinic and Hospital, Incorporated
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Kailua
	Castle Medical Center
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Lihue
	Kauai Medical Clinic
		Jeffrey Berenberg, MD	Ph:  808-433-4089
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Illinois
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-4750
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Robert Chapman, MD	Ph:  313-916-1332
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
North Carolina
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Statesville
	Iredell Memorial Hospital
		Ruby Grimm, MD	Ph:  704-873-2219
Ohio
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	Cancer Centers of the Carolinas - Grove Commons
		Clinical Trials Office - Cancer Centers of the Carolinas	Ph:  864-241-6251
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	Greer
	Cancer Centers of the Carolinas - Greer Medical Oncology
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	Seneca
	Cancer Centers of the Carolinas - Seneca
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
Washington
	Anacortes
	Island Hospital Cancer Care Center at Island Hospital
		Saul Rivkin, MD	Ph:  206-386-2441
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2441
	Burien
	Highline Medical Center Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Issaquah
	Swedish Medical Center - Issaquah Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	Kennewick
	Columbia Basin Hematology
		Saul Rivkin, MD	Ph:  206-386-2441
	Mount Vernon
	Skagit Valley Hospital Cancer Care Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Poulsbo
	Harrison Poulsbo Hematology and Onocology
		Saul Rivkin, MD	Ph:  206-386-2441
	Seattle
	Fred Hutchinson Cancer Research Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900
	Harborview Medical Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Minor and James Medical, PLLC
		Saul Rivkin, MD	Ph:  206-386-2441
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	University Cancer Center at University of Washington Medical Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Sedro-Woolley
	North Puget Oncology at United General Hospital
		Saul Rivkin, MD	Ph:  206-386-2441
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Evergreen Hematology and Oncology, PS
		Saul Rivkin, MD	Ph:  206-386-2441
	Wenatchee
	Wenatchee Valley Medical Center
		Clinical Trials Office - Wenatchee Valley Medical Center	Ph:  509-665-5800
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Registry Information
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
Trial Start Date		2010-05-12
Trial Completion Date		2011-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT01064648
Date Submitted to PDQ		2010-02-01
Information Last Verified		2012-05-22
NCI Grant/Contract Number		CA32102

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