Condition category
Cancer
Date applied
14/08/2007
Date assigned
02/10/2007
Last edited
15/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Nowak

ORCID ID

Contact details

Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA
6009
Australia
+61 (0)8 9346 3841
anna.nowak@health.wa.gov.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2005-195

Study information

Scientific title

Acronym

Study hypothesis

Sunitinib maleate will show anti-tumour activity in terms of objective tumour responses in malignant pleural mesothelioma following failure of first line chemotherapy.

Ethics approval

Ethics approval received from the Sir Charles Gairdner Hospital Human Research Ethics Committee in 2005.

Study design

Non-randomised, phase II, interventional, one-armed, non-controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malignant pleural mesothelioma

Intervention

Sunitinib 50 mg orally (po) daily x 28 days every 42 days. Treatment continues indefinitely for as long as the patient is receiving benefit (i.e., stable disease or objective response), is not experiencing toxicities requiring withdrawal of study drug, does not withdraw consent to participate, and is considered fit to continue by the investigator. Duration of follow-up is to death.

Intervention type

Drug

Phase

Phase II

Drug names

Sunitinib maleate (Sutent [SU11248])

Primary outcome measures

Objective response rate, assessed with the Modified RECIST criteria using spiral Computed Tomography (CT) scan at baseline, 6 weeks, 12 weeks, then 12-weekly thereafter while on study.

Secondary outcome measures

1. Time to Tumour Progression (TTP), assessed from study enrolment to tumour progression as per the Modified RECIST criteria
2. Time To Treatment Failure (TTTF), assessed from study enrolment to cessation of study treatment for any reason
3. Overall Survival, assessed from study enrolment and including death from all causes
4. Change in Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC)
5. Change in serum mesothelin
6. Adverse events and defined by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
7. Positron Emission Tomography (PET) response is assessed using 2-Fluoro-deoxy-D-Glucose (FDG) PET scan at baseline and at 6 weeks only

Overall trial start date

27/06/2006

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients must fulfill all the following criteria to be eligible for this study:
1. Histologically or cytologically confirmed diagnosis of malignant mesothelioma of the pleura
2. Previous therapy with at least one cycle of a platinum analogue and an antimetabolite with documented progression on, or after completion of, first-line therapy
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
4. One or more measurable lesions (by Modified Response Evaluation Criteria in Solid Tumours [RECIST] criteria)
5. Life expectancy greater than 12 weeks
6. Women of child-bearing age must use effective contraception
7. Adequate bone marrow function defined as:
7.1. Granulocyte count greater than 1.5 x 10^9/L
7.2. Platelet count greater than 100 x 10^9/L
7.3. Haemoglobin greater than 10 g/dl
8. Adequate renal function: calculated creatinine clearance (Cockcroft-Gault formula) greater than 45 ml/min
9. Adequate hepatic function defined as a total bilirubin less than Upper Limit of Normal (ULN), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) less than 2.5 x ULN, or 1.5 x ULN if Alkaline Phosphatase (Alk Phos) less than 2.5 x ULN. Alk Phos less than 5 x ULN unless patient has bone metastases
10. Ability to give fully informed written consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and to comply with the instructions in the protocol

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

51

Participant exclusion criteria

Any one of the following criteria will render a patient ineligible for this trial:
1. Previous second-line systemic chemotherapy for malignant mesothelioma
2. ECOG performance status greater than or equal to 2
3. Mesothelioma originating outside the pleura (e.g., peritoneum)
4. Previous radiotherapy to all measurable lesions
5. Symptomatic central nervous system involvement
6. Pregnancy or lactation
7. Serious concomitant systemic disorders incompatible with the study at the discretion of the investigator, e.g., severe peripheral neuropathy
8. Second primary malignancy diagnosed within the last 5 years (except for adequately treated non-melanoma skin cancers and in-situ cervical carcinoma adequately treated by cone excision)

Recruitment start date

27/06/2006

Recruitment end date

01/12/2008

Locations

Countries of recruitment

Australia

Trial participating centre

Department of Medical Oncology
Nedlands WA
6009
Australia

Sponsor information

Organisation

Sir Charles Gairdner Hospital (Australia)

Sponsor details

Hospital Avenue
Nedlands WA
6009
Australia

Sponsor type

Hospital/treatment centre

Website

http://www.scgh.health.wa.gov.au/

Funders

Funder type

Industry

Funder name

Pfizer (Australia) (ref: IIR 2005-0777)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes