A Randomised trial of predictive assay-directed chemotherapy in non-small cell lung cancer (NSCLC) and mesothelioma

Phase 2

Recruiting

• Conditions: on small cell lung cancer; Mesothelioma; Lung Cancer; Non small cell lung cancer; Cancer - Lung - Non small cell; Cancer - Lung - Mesothelioma

• Registration Number: ACTRN12611000728932
• Lead Sponsor: Ballarat Cancer Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified