Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00243074
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : October 21, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 20, 2005
First Posted Date  ICMJE October 21, 2005
Results First Submitted Date  ICMJE October 30, 2012
Results First Posted Date  ICMJE October 21, 2015
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE November 2005
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
Overall Response Rate [ Time Frame: Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years. ]
confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
  • Overall Survival [ Time Frame: Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years. ]
    From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
  • Progression-free Survival [ Time Frame: Every 8 weeks until disease progression or death, up to 5 years. ]
    From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
  • Disease Control Rate [ Time Frame: Every 8 weeks until disease progression progression, up to 5 years. ]
    The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.
  • Objective Response Rate Per Modified RECIST for Pleural Tumors [ Time Frame: Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years. ]
    The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.
  • Adverse Event Rates [ Time Frame: Daily during protocol treatment ]
    Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.
  • Adverse Events [ Time Frame: Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years. ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
Official Title  ICMJE A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Brief Summary This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. AZD2171 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
Detailed Description

PRIMARY OBJECTIVES:

I. Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171.

SECONDARY OBJECTIVES:

I. Determine the clinical benefit, in terms of objective response and stable disease rates, in patients treated with this drug.

II. Determine the 1-year median overall survival and progression-free survival in patients treated with this drug.

III. Determine the frequency and severity of toxic effects in patients treated with this drug.

IV. Correlate, preliminarily, pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug.

V. Correlate, preliminarily, circulating endothelial cells with clinical outcomes in patients treated with this drug.

VI. Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients.

OUTLINE:

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years from study entry.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignant Mesothelioma
  • Epithelial Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
Intervention  ICMJE
  • Drug: cediranib maleate
    Given orally
    Other Names:
    • AZD2171
    • Recentin
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: cediranib maleate
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2015)
54
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural mesothelioma

    • Unresectable disease

      • Residual disease after prior cytoreductive surgery allowed
  • Measurable disease by CT scan or MRI
  • Prior treatment with platinum-based chemotherapy required
  • No known CNS metastasis
  • Performance status

    • Zubrod 0-2
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • AST or ALT =< 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Creatinine =< 1.5 times ULN OR
  • Creatinine clearance >= 50 mL/min
  • Proteinuria =< 1+ by 2 consecutive dipstick tests taken >= 1 week apart
  • No history of familial long QT syndrome
  • Mean QTc =< 470 msec
  • Systolic BP =< 150 mm Hg AND diastolic BP =< 100 mm Hg
  • Must have New York Heart Association class I or II disease

    • Class II must be controlled with treatment
  • Able to swallow and/or receive enteral medications via gastrostomy feeding tube
  • Not requiring IV alimentation
  • No active peptic ulcer
  • No intractable nausea or vomiting
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in remission
  • No history of hypersensitivity reaction to compounds of similar chemical or biological composition to the study drug
  • Prior monoclonal antibody therapy targeting vascular endothelial growth factor (VEGF), VEGF receptor 1(VEGFR1) or VEGF receptor 2 (VEGFR2) allowed
  • No other prior immunotherapy or biologic therapy
  • No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2
  • No concurrent drugs or biologics with proarrhythmic potential
  • No more than 1 prior chemotherapy regimen
  • At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered
  • At least 21 days since prior radiotherapy and recovered
  • At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and recovered
  • No prior surgery that would affect absorption
  • Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are met
  • Concurrent enrollment on SWOG-S9925 allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00243074
Other Study ID Numbers  ICMJE NCI-2012-02902
S0509
U10CA032102 ( U.S. NIH Grant/Contract )
CDR0000446178 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda Garland Southwest Oncology Group
PRS Account National Cancer Institute (NCI)
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP