Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Anne Tsao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02015

NCT ID:

NCT01064648

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Advanced Malignant Mesothelioma
  • Epithelial Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
  • Mesothelioma

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