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 CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Henry Ford HospitalDetroit, Michigan  48202
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Regional Medical CenterKalispell, Montana  59901
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Iredell Memorial HospitalStatesville, North Carolina  28677
Grandview HospitalDayton, Ohio  45405
Danville Regional Medical CenterDanville, Virginia  24541
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Northeast Georgia Medical CenterGainesville, Georgia  30501
Miami Valley HospitalDayton, Ohio  45409
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Wayne HospitalGreenville, Ohio  45331
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Greene Memorial HospitalXenia, Ohio  45385
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Memorial Medical CenterSpringfield, Illinois  62781
Wellmont Holston Valley Hospital and Medical CenterKingsport, Tennessee  37662
Queen's Medical CenterHonolulu, Hawaii  96813
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Wayne State UniversityDetroit, Michigan  48202
Straub Clinic and HospitalHonolulu, Hawaii  96813
Kaiser PermanenteSacramento, California  
University of KentuckyLexington, Kentucky  40536-0098
Montana Cancer Consortium CCOPBillings, Montana  59101
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Decatur Memorial HospitalDecatur, Illinois  62526
Montana Cancer SpecialistsMissoula, Montana  59807-7877
M D Anderson Cancer CenterHouston, Texas  77030
University of Southern CaliforniaLos Angeles, California  90033
Castle Medical CenterKailua, Hawaii  96734
Highlands Oncology Group-BentonvilleBentonville, Arkansas  72712
Kaiser Permanente, FremontFremont, California  94538
Kaiser Permanente, HaywardHayward, California  94545
Kaiser Permanente-OaklandOakland, California  94611
Kaiser Permanente-Redwood CityRedwood City, California  94063
Kaiser Permanente-RichmondRichmond, California  94801
Kaiser Permanente-RosevilleRoseville, California  95661
Kaiser Permanente-South SacramentoSacramento, California  95823
Kaiser Permanente - SacramentoSacramento, California  95825
Kaiser Permanente-San FranciscoSan Francisco, California  94115
Kaiser Permanente-Santa Teresa-San JoseSan Jose, California  95119
Kaiser Permanente-San RafaelSan Rafael, California  94903
Kaiser Permanente-Santa RosaSanta Rosa, California  95403
Kaiser Permanente-South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente-StocktonStockton, California  95210
Kaiser Permanente-VallejoVallejo, California  94589
Kaiser Permanente-Walnut CreekWalnut Creek, California  94596
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
Oncare Hawaii Inc-POB IIHonolulu, Hawaii  96813
Oncare Hawaii Inc-KuakiniHonolulu, Hawaii  96817
University of HawaiiHonolulu, Hawaii  96813
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Upper Valley Medical CenterTroy, Ohio  45373
Greenville CCOPGreenville, South Carolina  29615
Greenville Memorial HospitalGreenville, South Carolina  29605
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
University of Michigan University HospitalAnn Arbor, Michigan  48109
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Medical OncologyGreer, South Carolina  29650
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Kuakini Medical CenterHonolulu, Hawaii  96817
Kaiser Permanente-Deer Valley Medical CenterAntioch, California  94531
Kaiser Permanente Medical Center-VacavilleVacaville, California  95688
Kaiser Permanente Moanalua Medical CenterHonolulu, Hawaii  96819
Wilcox Memorial Hospital and Kauai Medical ClinicLihue, Hawaii  96766-1099
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
United General HospitalSedro-Woolley, Washington  98284
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Franciscan St. Francis HealthIndianapolis, Indiana  46237
Southwest Oncology GroupSan Antonio, Texas  78245
Southwest Oncology Group (SWOG) Research BaseSan Antonio, Texas  78245
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
OnCare Hawaii-LilihaHonolulu, Hawaii  96817-3169
Oncare Hawaii Inc - Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Swedish Medical Center-EdmondsEdmonds, Washington  98026
Kaiser Permanente-ModestoModesto, California  95356