Brief Summary
Lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs is the most common cause of cancer-related deaths. Although some improvements in the treatment of early stage lung cancer have occurred, the majority of participants still present with advancedat a late stage, far along (non-operable) disease. The treatments for participants with advanced lung cancer are mostly palliative using various treatments, including chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, targeted therapies and radiotherapy. This study looks at whether response rates to an assay-directed chemotherapy regime – adenosine triphosphate tumoura tissue mass that forms from groups of unhealthy cells cell assay (ATP-TCA) – may be greater than in patients who are receiving current, standard chemotherapy for lung cancer.
Intervention/Treatment
- Drug: Carboplatin
- Drug: Docetaxel
- Drug: Pemetrexed
- Drug: Vineralbine
- Drug: Gemcitabine
- Drug: Irinotecan
- Drug: Abraxane
Inclusion Criteria
- Participants with a confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of inoperable non small cell lung cancer or mesothelioma aged >18 years.
- ECOG performance status of 0, 1 or 2.
- Stage IIIB or stage IV NSCLC or mesothelioma.
- Life expectancy of at least 3 months.
- One lesion amenable to thoroscopic biopsyremoval of a section of tissue to analyse for cancer cells.
- Presence of one measurable lesion as per RESIT criteria.
- No previous radiotherapy.
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells function:
- Neutrophil count > 1.5 x 109/L.
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding = 100 x 109/L.
- Haemoglobin > 100g/L.
- Adequate hepatic function:
- Bilirubin < upper limit for institution (except Gilberts disease).
- ALT/AST = <1.5 x ULN for institution. In situations where the participant has liver metastasises an elevated <5 x ULN is acceptable.
- Alkaline phosphatase = <2.5 x ULN for institution.
- Adequate renal function:
- Creatine within normal institutional limits OR
- Creatine clearance >60 ml/min for participant with creatine levels above institutional normal range. (either measured or calculated using Cockroft-Gault formula).
- At least 2 million viable cancer cellsthe basic structural and functional unit of all living things recoverable from a biopsy or pleural aspiration.
- Participants must be able commence treatment within 7 days of ATP-TCA test result.
- Women of child-bearing potential must have a negative pregnancy test and agree to use an accepted and effective method of non-hormonal barrier contraception (barrier method of birth control, abstinence.
- An ability to understand and the willingness to sign a written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. document.
- Participants must be accessible for follow up.
- Participants must be informed of and agree to data and tissuea group of cells that work together to perform a function material transfer and handling, in accordance with national data protection guidelines.