NCT00309946

Brief Summary

This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery. Cediranib maleate 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 10, 2013

Completed
Last Updated

July 31, 2014

Status Verified

October 1, 2013

Enrollment Period

4.8 years

First QC Date

March 29, 2006

Results QC Date

July 1, 2013

Last Update Submit

July 25, 2014

Conditions

Advanced Malignant MesotheliomaEpithelial MesotheliomaLocalized Malignant MesotheliomaRecurrent Malignant MesotheliomaSarcomatous Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate, Complete (CR) or Partial (PR) Response

    Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.

    Every 8 weeks

Secondary Outcomes (2)

  • Changes in Laboratory Correlates

    Baseline, days 15 and 29 of course 1, and then every 28 days

  • Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity

    Week 1 of course 1

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.

Drug: cediranib maleate

Interventions

cediranib maleateDRUG

Given orally

Also known as: AZD2171, Recentin
Treatment (enzyme inhibitor therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma
  • Epithelial, sarcomatoid, or mixed subtype
  • International Mesothelioma Interest Group stage II-IV disease (for patients with pleural mesothelioma)
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
  • Pleural effusion and ascites are not considered measurable lesions
  • Disease not amenable to curative surgery
  • No known brain metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy \> 3 months
  • White blood cell (WBC) ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 8 g/dL
  • Platelets ≥ 100,000/mm³
  • Total bilirubin normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal(ULN)
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Related Publications (1)

  • Campbell NP, Kunnavakkam R, Leighl N, Vincent MD, Gandara DR, Koczywas M, Gitlitz BJ, Agamah E, Thomas SP, Stadler WM, Vokes EE, Kindler HL. Cediranib in patients with malignant mesothelioma: a phase II trial of the University of Chicago Phase II Consortium. Lung Cancer. 2012 Oct;78(1):76-80. doi: 10.1016/j.lungcan.2012.06.011. Epub 2012 Jul 23.

    PMID: 22831987RESULT

MeSH Terms

Conditions

Mesothelioma, MalignantSolitary Fibrous Tumor, Pleural

Interventions

cediranib

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesSolitary Fibrous TumorsNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Results Point of Contact

Title
Dr. Hedy Kindler
Organization
The University of Chicago
hkindler@medicine.bsd.uchicago.edu
(773) 702-0360

Study Officials

  • Hedy Kindler

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

December 1, 2005

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 31, 2014

Results First Posted

September 10, 2013

Record last verified: 2013-10

Locations

US(1)