ACTRN12612000473864
Not yet recruiting
Phase 2
A randomized phase 2 study to evaluate the effect of carboplatin with oral vinorelbine (navelbine [Registered Trademark]) followed by maintenance therapy with oral vinorelbine (navelbine [Registered Trademark]) or erlotinib (Tarceva [Registered Trademark]) on quality of life and progression free survival in metastatic non-small cell lung cancer in elderly patients.
Southern Health0 sites100 target enrollmentMay 1, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- on Small Cell Lung Cancer
- Sponsor
- Southern Health
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients \> 70 years old,
- •2\. Histologically or cytologically proven non\-small cell lung cancer,
- •3\. Stage 3B (not suitable for radical radiotherapy) or stage 4(7th IALC staging edition),
- •4\. PS 0\-1
- •5\. Life expectancy \> 12 weeks
- •6\. Adequate bone marrow, hepatic and renal function
Exclusion Criteria
- •1\. Known hypersensitivity to drugs with similar chemical structures to study medication,
- •2\. Active CNS disorder, symptomatic brain or leptomeningeal metastasis or CNS disease requiring steroid therapy,
- •3\. Symptomatic neuropathy (sensory) \> grade 1 according to the NCI Common Toxicity Criteria,
- •4\. Cardiovascular disease (uncontrolled cardiac failure, or myocardial infraction within the previous 3 months, uncontrolled hypertension or arrhythmia),
- •5\. Active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment,
- •6\. Superior vena cava syndrome,
- •7\. Long term oxygen therapy,
- •8\. Unstable pleural effusion,
- •9\. Unstable ascites or pericardial effusion,
- •10\. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
A randomised phase II study to evaluate the effectiveness of botulinum toxin to delay, and possibly prevent, progressive foot deformities in children with Charcot-Marie-Tooth (CMT) disease.Charcot-Marie-Tooth diseaseHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersNeurological - Other neurological disordersACTRN12605000115639The Children's Hospital at Westmead10
Recruiting
Phase 1
Effects of natural seaweed extract (GFS) on mobilisation of human bone marrow stem cells and immune system activatioormal volunteersNormal volunteersOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveInflammatory and Immune System - Normal development and function of the immune systemACTRN12605000021673Tas100
Active, not recruiting
Not Applicable
EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancerPatients aged 65 years or older with histologically or cytologically confirmed breast cancer, locally recurrent and/or metastaticany estrogen/progesterone receptor statusHER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapyMedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-002707-18-ITFONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS
Not yet recruiting
Phase 2
A clinical trial to check the efficacy and safety of MEDI-546 (Study drug) in subjects with Systemic Lupus ErythematosusHealth Condition 1: null- Systemic Lupus ErythematosusCTRI/2012/12/003190MedImmune LLC a member of the AstraZeneca Group of300
Active, not recruiting
Phase 1
AEUCTR2011-004296-36-BGMedImmune, LLC,300