A phase II study of Sutent (SU11248) as second line treatment in pleural mesothelioma after first line treatment with a platinum and antimetabolite

ISRCTN ISRCTN03334163
DOI https://doi.org/10.1186/ISRCTN03334163
Secondary identifying numbers 2005-195
Submission date
14/08/2007
Registration date
02/10/2007
Last edited
15/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anna Nowak
Scientific

Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA
6009
Australia

Phone +61 (0)8 9346 3841
Email anna.nowak@health.wa.gov.au

Study information

Study designNon-randomised, phase II, interventional, one-armed, non-controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesSunitinib maleate will show anti-tumour activity in terms of objective tumour responses in malignant pleural mesothelioma following failure of first line chemotherapy.
Ethics approval(s)Ethics approval received from the Sir Charles Gairdner Hospital Human Research Ethics Committee in 2005.
Health condition(s) or problem(s) studiedMalignant pleural mesothelioma
InterventionSunitinib 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Sunitinib maleate (Sutent [SU11248])
Primary outcome measureObjective 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 measures1. 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 study start date27/06/2006
Completion date01/12/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants51
Key inclusion criteriaPatients 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
Key exclusion criteriaAny 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)
Date of first enrolment27/06/2006
Date of final enrolment01/12/2008

Locations

Countries of recruitment

  • Australia

Study participating centre

Department of Medical Oncology
Nedlands WA
6009
Australia

Sponsor information

Sir Charles Gairdner Hospital (Australia)
Hospital/treatment centre

Hospital Avenue
Nedlands WA
6009
Australia

Website http://www.scgh.health.wa.gov.au/
ROR logo "ROR" https://ror.org/01hhqsm59

Funders

Funder type

Industry

Pfizer (Australia) (ref: IIR 2005-0777)
Government organisation / For-profit companies (industry)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan