NCT00243074

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 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

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

October 21, 2015

Completed
Last Updated

January 23, 2018

Status Verified

February 1, 2014

Enrollment Period

4.4 years

First QC Date

October 20, 2005

Results QC Date

October 30, 2012

Last Update Submit

December 27, 2017

Conditions

Advanced Malignant MesotheliomaEpithelial MesotheliomaRecurrent Malignant MesotheliomaSarcomatous Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    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.".

    Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.

Secondary Outcomes (6)

  • Overall Survival

    Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.

  • Progression-free Survival

    Every 8 weeks until disease progression or death, up to 5 years.

  • Disease Control Rate

    Every 8 weeks until disease progression progression, up to 5 years.

  • Objective Response Rate Per Modified RECIST for Pleural Tumors

    Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.

  • Adverse Event Rates

    Daily during protocol treatment

  • +1 more secondary outcomes

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

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

Drug: cediranib maleateOther: laboratory biomarker analysis

Interventions

cediranib maleateDRUG

Given orally

Also known as: AZD2171, Recentin
Treatment (cediranib maleate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (cediranib maleate)

Eligibility Criteria

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

You may qualify if:

  • 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
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

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
Lung Committee Statistician
Organization
SWOG Statistical Center
jmoon@fredhutch.org
206-667-4623

Study Officials

  • Linda Garland

    SWOG Cancer Research Network

    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

October 20, 2005

First Posted

October 21, 2005

Study Start

November 1, 2005

Primary Completion

April 1, 2010

Study Completion

December 1, 2011

Last Updated

January 23, 2018

Results First Posted

October 21, 2015

Record last verified: 2014-02

Locations

US(1)