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 measure
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 (if study stopped)
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
Funders
Funder type
Industry
Funder name
Pfizer (Australia) (ref: IIR 2005-0777)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list