Lung and Mesothelioma

Registered Title

A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients with Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease.

Purpose

This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer.

PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer. 

Lay Summary

This study looks at the effectiveness of treatment with the drug PF-804 in patients with incurable non-small cell lung cancer, where standard therapy for advanced or widespread disease has not been successful.

Who is it for?
You can join this study if you have a confirmed diagnosis of non-small cell carcinoma of the lung, described as incurable stage IIIB or IV, where standard therapy has not been successful.

Trial details
Participants will be randomly divided into two groups. One group will receive a non-active (placebo) treatment, and the other will receive treatment with the drug PF-804, both taken orally (in cycles of 28 days)until the disease progresses or toxicity is unacceptable. The aim is to compare the overall survival between the two groups, and to monitor the effects of the treatment. PF-804 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

US National Library of Medicine

Australian New Zealand Clinical Trials Registry

Registered Title

A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung.

Purpose

This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

Lay Summary

N/A

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

US National Library of Medicine

Registered Title

MAGRIT-A3: A double-blind, randomised, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung Cancer.

Purpose

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumour. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Lay Summary

N/A

WA Trial Sites

RPH Medical Oncology
Ph. (08) 9224 1317

Links

US National Library of Medicine

Registered Title

Purpose

This randomized, placebo-controlled, multicenter study will test the hypothesis that farletuzumab can add to the efficacy of a platinum containing doublet in Stage IV adenocarcinoma of the lung.

Lay Summary

N/A

WA Trial Sites

Fremantle Hospital
Ph. (08) 9431 2729

Links

US National Library of Medicine

Registered Title

A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer.

Purpose

The aim of this trial is to determine the effects of adding transdermal nitroglycerin to first line chemotherapy.

The primary objective is to determine its effect on progression-free survival (PFS).

Secondary objectives are to determine its effects on: overall survival (OS), objective tumour response (OTR), adverse events (AE), and health-related quality of life (HRQL).

The underlying hypotheses are that addition of nitroglycerin will lead to an improvement in PFS and also favourably affect OS, OTR and HRQL, and that adverse events will be infrequent and mild.

Lay Summary

N/A

WA Trial Sites

RPH Medical Oncology
Ph. (08) 9224 1317

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

Australian New Zealand Clinical Trials Registry

Registered Title

PACT in NSCLC: Preferences for adjuvant chemotherapy in non-small cell lung cancer: What makes it worthwhile to patients and their doctors?

Purpose

N/A

Lay Summary

N/A

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

N/A

Registered Title

The Effect of Pharmacogenetics on Treatment Toxicities and Outcomes in East Asian and Caucasian Patients Undergoing Docetaxel or Gemcitabine-Based Chemotherapy.

Purpose

Germ line polymorphisms are inherited genetic variations present in all cells of the body. Mounting evidence has shown that genetic polymorphisms in drug metabolizing, transporter and targets genes are major determinants of response to drugs.

To date, most pharmacogenetic strategies are predominantly focused on the role of single genes, in the regulation of drug metabolism. However, there is clear evidence that treatment outcomes are under the control of a network of genes, each contributing to the patient's phenotype. In this study, we propose taking a global approach to include relevant candidate genes in drug pathways to evaluate the effect of polymorphisms and treatment outcomes. We have selected two commonly used chemotherapy regimens based on our previous observation of inter-ethnic variability in treatment outcomes and candidate polymorphisms.

The aims of this study are:

1. To compare the toxicity profile and efficacy of gemcitabine/carboplatin or docetaxel in East Asian and Caucasian patients.
2. To determine the genotype distribution of genes involved in docetaxel and gemcitabine pathways in East Asian and Caucasian patients.
3. To evaluate the association between genotypes and

a. treatment toxicity
b. treatment efficacy
c. pharmacokinetics.

Lay Summary

N/A

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

US National Library of Medicine

Registered Title

A Randomised Phase III Trial of Highly Conformal Hypofractionated Image Guided ("Stereotactic") Radiotherapy (HypoRT) Versus Conventionally Fractionated Radiotherapy (ConRT) for Inoperable Early Stage I Non Small Cell Lung Cancer.

Purpose

The purpose of this study is to investigate whether radiotherapy given as three large doses over a period of two weeks (hypofractionated radiotherapy) is more effective than standard radiotherapy for patients with non-small cell lung cancer that has not spread beyond the lung. Although surgery is the most effective treatment for early lung cancer, many patients are not fit enough for an operation. The alternative treatment to surgery is standard radiotherapy which is normally 'fractionated' that is, given as a number of small doses over a period of weeks.

Experience has shown that many small treatments are safer then using a few large doses (hypofractionation) because there is less risk of damage to the normal tissues. Recent advances in technology have however resulted in greater accuracy and with it a reduction in the amount of normal tissue affected by the radiation, so the risks of hypofractionation damaging normal tissue are of less concern. Initial results obtained with hypofractionated radiotherapy for early stage non-small cell lung cancer indicate that it may be more effective in controlling the cancer. However, it has never been compared directly with standard fractionation in a randomised trial, so this study aims to determine if hypofractionation is more effective, results in longer life expectancy and if it is just as safe as standard fractionation.

Lay Summary

N/A

WA Trial Sites

SCGH Radiation Oncology
Ph. (08) 9346 4900

Links

Trans-Tasman Radiation Oncology Group

Registered Title

B2P2M2: Phase II, single arm trial to evaluate the response rate of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma.

Purpose

At present there is no standard 2nd line chemotherapy regime for patients with advanced malignant pleural mesothelioma (MPM) who progress after treatment with standard first line chemotherapy (i.e. pemetrexed and a platinum compound). BNC105P is a novel chemotherapy agent which has shown activity in MPM. In this study, BNC105P will be studied in a single arm, 2 stage, multi-centre design to determine its efficacy and safety as 2nd line chemotherapy for patients with MPM. All subjects will receive BNC105P on Day 1 and Day 8 of a 21 day cycle until unacceptable toxicity or disease progression. The primary endpoint will be tumour response, and secondary endpoints include progression-free survival, overall survival, adverse events, and quality of life. Correlative substudies will examine associations between potential biological markers and outcomes.

Lay Summary

N/A

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

Australia New Zealand Clinical Trials Registry

Registered Title

CD-40 Activating Anti-body (CP-870,893) in Combination with Cisplatin and Pemetrexed in Unresectable Malignant Mesothelioma: A Phase 1 Study.

Purpose and Summary

The immune system often recognises cancer cells as ‘abnormal', and mounts an immune response to kill the cancer cells. However, this immune response is usually weak and cannot successfully fight the cancer on its own. Laboratory research has shown that chemotherapy can kill cancer cells but it can also allow the immune system to recognize the cancer more readily. Combinations of chemotherapy containing the drug pemetrexed (Alimta) have been shown to do this, and to work better when used with antibodies similar to CP-870,893. CP-870,893 is an antibody that activates the immune system and may make it easier for the immune system to respond against the cancer cells.  In previous trials, when patients with different types of cancer received CP-870,893 on its own, a minority of patients had their cancers shrink or stay the same size for a period of time, indicating that CP-870,893 may have helped to control the cancer for a while.  This clinical trial is aiming to find out the safe dose of CP-870,893 to give to people with mesothelioma, in combination with their regular chemotherapy, in order to boost the activity of the immune system against the mesothelioma.  A further purpose of the research is to get information about how the immune system changes when CP-870,893 is combined with chemotherapy for the treatment of mesothelioma. To do this, we will collect, store, and use your blood samples to study your immune system and may use these samples to study proteins, and other components of your blood. 

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

Australian New Zealand Clinical Trials Registry

Registered Title

Optimising regulatory T cell depletion in combination with chemotherapy for enhanced anti-tumour immunity.

Purpose

This trial aims to study the use of oral cyclophosphamide in combination with cisplatin/carboplatin and pemetrexed or pemetrexed alone as a strategy to deplete regulatory T cells.

Cyclophosphamide dose is individualised to optimise regulatory T cell depletion in each patient. Both clinical and immunological outcomes are measured.

Lay Summary

People with malignant mesothelioma or non-small cell lung cancer who are planned to have chemotherapy with pemetrexed (Alimta) either alone or with cisplatin or carboplatin can participate in this study.

The aim of the study is to investigate whether the addition of the tablet cyclophosphamide can reduced the number of regulatory T cells in the blood. Regulatory T cells may suppress anti-tumour immunity, and there is evidence that decreasing the numbers of regulatory T cells may improve the ability of the body to fight cancer.

In this trial, participants will have regular blood tests to individualise the dose of cyclophosphamide in order to lower regulatory T cells numbers maximally and safely.

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

N/A

Registered Title

PART B:  Use of FDG - FLT PET in the Assessment of Tumour Extent and Tumour Response in Pleural Mesothelioma.

Purpose

N/A

Lay Summary

N/A

WA Trial Sites

SCGH Medical Oncology
Ph. (08) 9346 4608

Links

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