None listed
Conditions
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 advanced (non-operable) disease. The treatments for participants with advanced lung cancer are mostly palliative using various treatments, including chemotherapy, 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. Who is it for? You may be eligible for this study if you have had a confirmed diagnosis of inoperable non small cell lung cancer or mesothelioma, are 18 years and above in age, have an ECOG performance status of 0, 1 or 2, and adequate bone marrow, hepatic and renal function as determined by clinical assessments. Trial details In this trial, you will be treated with either an assay-directed chemotherapy regime, ATP-TCA, or your physician’s choice of standard therapy for your condition. Which treatment you will receive will be determined by randomisation. If you are randomised to the ATP-TCA arm, you will be offered therapy based on your chemo-sensitivity profiles, from which a list of drugs that were positive on the ATP-TCA assay will be provided to your treating oncologist to decide the best first-line chemotherapy agents for you, provided in standard doses based on current clinical practice. The chemotherapy drugs that will be tested in the ATP-TCA assays include: Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane). If you are randomised to the standard chemotherapy treatment, you will receive carboplatin and docetaxel administered every 3 weeks in standard doses. For both treatments, a total of 6 cycles will be administered providing there is evidence of stable disease or partial or complete response by the RECIST criteria. CT scans will be performed after the 3rd and 6th cycles of chemotherapy treatment. Should your disease progress past what is deemed suitable, your treating oncologist will then remove you from the study. Quality of-life assessments will be performed prior to cycle three of chemotherapy and following cycle The aim of this study is to test the hypothesis that the results of chemotherapy in non small cell lung cancer can be improved by predictive testing without an unacceptable increase in toxicity.
Interventions
Trial particaipants in the testing arm of the trial will recieve chemotherapy based on the results of chemosensitivity testing of tumour biopsy samples. The drugs used will be chemotherapy drugs currently already approved for the treatment of lung cancer.
Participants may recieve one of or a combination of the following drugs:Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane).
Standard drug doses will be administered by intravenous infusio
Trial particaipants in the testing arm of the trial will recieve chemotherapy based on the results of chemosensitivity testing of tumour biopsy samples. The drugs used will be chemotherapy drugs currently already approved for the treatment of lung cancer. Participants may recieve one of or a combination of the following drugs:Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane). Standard drug doses will be administered by intravenous infusion for up to 6 cycles of chemotherapy with each cyle lasting 3 weeks or until disease progression. Exact dose amounts will be determined by the treating oncologists. Particaipants in the control arm of the trails will recieve the standard of care chemotherapy for lung cancer which will consist of Carboplatin and Docetaxel. Standard drug doses will be administered by intravenous infusion for up to 6 cycles of chemotherapy with each cyle lasting 3 weeks as per The American Society of Clinical Oncologists (ASCO) guidelines or until disease progression. Exact dose amounts will be determined by the treating oncologists. At disease progression all participants will be excluded from the trial and will recieve the standard of care treatment as directed by the participants oncologists.
Sponsors
Ballarat Cancer Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 biopsy. . Presence of one measurable lesion as per RESIT criteria. . No previous radiotherapy. . Adequate bone marrow function. 1. Neutrophil count > 1.5 x 109/L 2. Platelets = 100 x 109/L 3. Haemoglobin > 100g/L . Adequate hepatic function. 1. Bilirubin < upper limit for institution (except Gilberts disease) 2. ALT/AST = <1.5 x ULN for institution. In situations where the participant has liver metastasises an elevated <5 x ULN is acceptable 3. Alkaline phosphatase = <2.5 x ULN for institution. . Adequate renal function. 1. Creatine within normal institutional limits OR 2. 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.
Exclusion criteria
Exclusion Criteria: . Participants may not be receiving any other investigational agents. . Congestive heart failure (New York Heart Association (NYHA) Class III-IV) or history of congestive failure, unstable angina pectoris, myocardial infarction in the last 6 months, poorly controlled hypertension ( systolic>180mmHg or diastolic > 100mm Hg), clinically significant valvular disease, or high risk uncontrolled arrhythmias. . History of significant neurologic or psychiatric disorders including psychotic disorders dementia or seizures that would prohibit the understanding and giving informed consent. . Participants with dyspnoea at rest due to malignant or other disease who require supportive oxygen therapy. . Participant who are pregnant or lactating at the time of registration to the trial . Any active uncontrolled infection . Any previous chemotherapy in the last 5 years for malignant disease. . Any medical condition which in the investigators opinion makes the subject unsuitable for study participation
Outcome results
None listed