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
Scientific
Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA
6009
Australia
| Phone | +61 (0)8 9346 3841 |
|---|---|
| anna.nowak@health.wa.gov.au |
Study information
| Study design | Non-randomised, phase II, interventional, one-armed, non-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the Sir Charles Gairdner Hospital Human Research Ethics Committee in 2005. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 27/06/2006 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 51 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 27/06/2006 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- Australia
Study participating centre
Department of Medical Oncology
Nedlands WA
6009
Australia
6009
Australia
Sponsor information
Sir Charles Gairdner Hospital (Australia)
Hospital/treatment centre
Hospital/treatment centre
Hospital Avenue
Nedlands WA
6009
Australia
| Website | http://www.scgh.health.wa.gov.au/ |
|---|---|
"ROR" |
https://ror.org/01hhqsm59 |
Funders
Funder type
Industry
Pfizer (Australia) (ref: IIR 2005-0777)
Government organisation / For-profit companies (industry)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
