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Trial registered on ANZCTR


Registration number
ACTRN12612000473864
Ethics application status
Not yet submitted
Date submitted
15/02/2012
Date registered
1/05/2012
Date last updated
1/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised phase 2 study of carboplatin with oral vinorelbine followed by maintenance therapy with oral vinorelbine or erlotinib in elderly patients with metastatic non-small cell lung cancer.
Scientific title
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.
Secondary ID [1] 279944 0
Nil
Universal Trial Number (UTN)
Trial acronym
OMEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 285860 0
Condition category
Condition code
Cancer 286042 286042 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Vinorelbine 60mg/m2 on day 1 and day 8 of 21 day cycle for 1st 2 cycles and then escalated to 80mg/m2 on day 1 and day 8 for further 2 cycles if no grade 3 toxicities were noticed, in combination with intravenous carboplatin at a dose calculated according to the formula of Calvert at AUC of 5, on day 1 of 21 day cycle. This induction treatment will be given for up to four cycles. Then maintenance treatment with either oral vinorelbine at dose given at the last cycle of induction therapy on day 1 and day 8 of 21 day cycle or Erlotinib 150mg orally continuously every day. The maintenance treatment with vinorelbine or Erlotinib will commence 3 weeks after the last cycle in induction phase of chemotherapy and will continue until documented disease progression, unaccepable toxicities, patient's refusal or investigatior's decision based on the best interests of the patient.
Intervention code [1] 284274 0
Treatment: Drugs
Comparator / control treatment
The comparison is between maintainence treatment with either Erlotinib 150 mg orally every day or oral Vinorelbine at the same dose given at the last cycle of induction chemotherapy on day 1 and day 8 of 21 day cycle to be commenced after 3 weeks of completion of induction treatment. Both groups will receive the same induction treatment.
Control group
Active

Outcomes
Primary outcome [1] 286527 0
Primary outcome 1: To determine quality of life using the EORTC QLC 30 and LC 13 subscale.
Timepoint [1] 286527 0
Primary Endpoint: assessed by qauality of life questionaire (EORTC QLC 30 and LC 13 subscale) every 6 weeks until disease progression, death or unacceptible toxicities.
Primary outcome [2] 286665 0
Primary outcome 2: To determine the progression free survival (defined as time from randomization till disease progression or death due to any reason) of elderly patients receiving maintenance therapy with oral vinorelbine or erlotinib following combination chemotherapy with up to 4 cycles of carboplatin and oral vinorelbine.
Timepoint [2] 286665 0
Primary outcome 2:assessed by performing CT scans every 6 weeks until disease progression, death or unacceptible toxicities.
Secondary outcome [1] 296087 0
Secondary outcome 1: To further determine the response rate, duration of response, and overall survival.
Timepoint [1] 296087 0
Secondary outcome 1: assessed by performing CT scans every 6 weeks until disease progression, death or unacceptible toxicities.
Secondary outcome [2] 296409 0
Secondary outcome 2: To assess the safety and toxicity profile of maintenance therapy
Timepoint [2] 296409 0
Secondary outcome 2: Assessed every 3 weeks in induction phase by history, clinical examination and blood tests and 6 weekly in maintenance phase

Eligibility
Key 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
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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,
11. Radiotherapy within the previous 2 weeks,
12. Concomitant treatment with any other anticancer agent,
13. Uncontrolled hypercalcaemia,
14. Unstable concomitant disease,
15. Concomitant treatment with corticosteroids except chronic treatment ( > 1 month) at low dosing ( < 20 mg/ day of methylprednisolone or equivalent),
16. Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function,
17. Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to study screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients will be given induction chemotherapy with oral Vinorelbie with Carboplatin every 3 weeks for up to 4 cycles. Pateints with non progressive disease will be randomised to receive either oral Vinorelbine or oral Erlotinib until disese progression, unacceptable toxicities, death of patient withdrawal from the study. Method used for allocation concealment will be through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284930 0
Commercial sector/Industry
Name [1] 284930 0
Pierre Fabre
Address [1] 284930 0
Suite 3B, 1 Richardson Place
North Ryde
NSW 2113
Australia
Country [1] 284930 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Country
Australia
Secondary sponsor category [1] 283612 0
None
Name [1] 283612 0
Address [1] 283612 0
Country [1] 283612 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286718 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 286718 0
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Ethics committee country [1] 286718 0
Australia
Date submitted for ethics approval [1] 286718 0
01/12/2011
Approval date [1] 286718 0
Ethics approval number [1] 286718 0
11371A

Summary
Brief summary
This study will evaluate the safety and efficacy of induction chemotherapy followed by maintenance with one of the two different drugs in elderly patients with metastatic non-small cell lung cancer.

Who is it for?
you may be eligible to join this study if you are male or female above 70 years and you have been diagnosed with metastatic non-small cell lung cancer.

Trial details
All participants will undergo upto 4 x 3 weeks cycles of induction chemotherapy with the drugs vinorelbine (taken as an oral tablet) and carboplatin administered into the vein (intravenously). Participants whose disease has not progressed will then be randomly (by chance) allocated to one of two groups. One group will take a vinorelbine capsule on day 1 and 8 of 3 week cycle. Participants in the other group will take one Erlotinib tablet every day. Participants in both groups will take the treatment till progression of disease, unacceptable side effects or if patient chooses not to continue the treatment.
Participants will be assessed every 3-6 weeks until disease progression, death or unacceptable toxicities in order to determine quality of life and response to treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33778 0
Address 33778 0
Country 33778 0
Phone 33778 0
Fax 33778 0
Email 33778 0
Contact person for public queries
Name 17025 0
Mr Peter Midolo
Address 17025 0
Oncology Trials Manager
Monash Medical Centre
823-865 Centre Road
East Bentleigh
Victoria 3165
Country 17025 0
Australia
Phone 17025 0
+61 3 9928 8195
Fax 17025 0
+ 61 3 9928 8341
Email 17025 0
peter.midolo@southernhealth.org.au
Contact person for scientific queries
Name 7953 0
Dr Peter Briggs
Address 7953 0
Director of Medical Oncology
Monash Medical Centre
823-865 Centre Road
East Bentleigh
Victoria 3165
Country 7953 0
Australia
Phone 7953 0
+61 3 9928 8120
Fax 7953 0
+ 61 3 9928 8341
Email 7953 0
peter.briggs@southernhealth.org.au

No information has been provided regarding IPD availability
Summary results
No Results