Malignant pleural mesothelioma Cancer Mesothelioma of pleura
Conditions
Interventions
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 experie
Sponsors
Sir Charles Gairdner Hospital (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia
Outcome results
None listed