None listed
Conditions
Brief 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.
Interventions
PF-804 administered orally once daily at a daily dose of 45mg (in 28 day cycles) until disease progression or unacceptable toxicity
Sponsors
NCIC Clinical Trials Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically confirmed diagnosis of non-small cell carcinoma of the lung. Patients must have evidence of disease, but measurable disease is not mandatory Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 Adequate renal and hepatic functions Patients must have recovered from any toxic effects and at least 21 days must have elapsed from the last dose and prior to randomization Patients < 70 years Must have received 1-2 prior chemotherapy regimens Patients > 70 years May have received 1 or 2 prior single agent chemotherapy regimens for their disease, Adjuvant Chemotherapy: Patients may ALSO have had prior adjuvant therapy for completely resected disease, providing completed at least 12 months prior to randomization. Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy: Patients may only be enrolled after failure of prior gefitinib or erlotinib for advanced or metastatic disease Radiation: Patients may have had prior radiation therapy provided that a minimum of 14 days has elapsed between the end of radiotherapy and randomization onto the study Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed Patient able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires. Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements Patients must be accessible for treatment and follow-up. protocol treatment is to begin within 2 working days of patient randomization.
Exclusion criteria
Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy. Patients who have experienced untreated and/or uncontrolled cardiovascular conditions Patients with a significant cardiac history, even if controlled, should have a left ventricular ejection fraction (LVEF) > 50%. Patients with untreated brain or meningeal metastases are not eligible (Computerised Tomography (CT) scans are not required to rule this out unless there is a clinical suspicion of Central Nervous System (CNS) disease). Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol Mean QTc (a measure of the time between the start of the Q wave and the end of the T wave) with Bazetts correction > 470msec in screening electrocardiogram (ECG) or history of familial long QT syndrome. Drugs that are highly dependent on Cytochrome P450 2D6 (CYP2D6) for metabolism are prohibited Pregnancy or inadequate contraception
Outcome results
None listed