Brief Summary
Lung cancer 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 tumour 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 diagnosis 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.
- Platelets = 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 cells 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 consent document.
- Participants must be accessible for follow up.
- Participants must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines.