Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000020088
Ethics application status
Approved
Date submitted
30/10/2009
Date registered
8/01/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II randomised study comparing the clinical benefit between Paclitaxel (Taxol) and oral Vinorelbine (Navelbine) in patients with stage IIIBw - IV non-small cell lung cancer (NSCLC), performance status (PS) 2
Scientific title
A phase II randomised study comparing the clinical benefit between Paclitaxel (Taxol) and oral Vinorelbine (Navelbine) in patients with stage IIIBw - IV non-small cell lung cancer (NSCLC), performance status (PS) 2
Secondary ID [1] 1219 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 251965 0
Condition category
Condition code
Cancer 252155 252155 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in Group B will receive Paclitaxel (Taxol) 90 mg/m2 IV (intravenous) for 1h on days 1, 8, 15 every 4 weeks for a total of 4 cycles. H2 blocker (H2 receptor agonists) antiemetics 8mg will be given iv prior to Paclitaxel
Intervention code [1] 241430 0
Treatment: Drugs
Comparator / control treatment
Group A patients will receive oral Vinorelbine (Navelbine) 60 mg/m2 on days 1, 8, 15 every 4 weeks for a total of 4 cycles. H2 blocker (H2 receptor agonists) anti-emetics 8 mg will be given orally prior to Vinorelbine
Control group
Active

Outcomes
Primary outcome [1] 253093 0
Clinical Benefit
Timepoint [1] 253093 0
Clinical benefit questionnaire will be completed by the end of the 2nd and 4th cycle of chemotherapy by the treatment physician
Secondary outcome [1] 257955 0
Survival
Timepoint [1] 257955 0
This outcome is assessed using clinical data records at the end of 4th cycle, then every 2 months for 1 year and every 4 months for the 2nd year thereafter.
Secondary outcome [2] 262114 0
Response
Timepoint [2] 262114 0
Patient will be fully evaluated with computed tomography (CT) scan, bone scan, X-ray, full blood tests and any other tests which are indicated following the 2nd and 4th cycle of chemotherapy
Secondary outcome [3] 262115 0
Toxicity
Timepoint [3] 262115 0
Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc. after each cycle
Secondary outcome [4] 262684 0
Time to Progression
Timepoint [4] 262684 0
Progression is assessed by physical examination, laboratory evaluation of hematology and biochemistry and imaging methods including computed tomography (CT) scan, bone scan, X-ray etc. It is assessed every 4 months for the 1st year and for the 2nd year thereafter.

Eligibility
Key inclusion criteria
Histologic proof of inoperable, recurrent or metastatic non-small cell lung cancer (NSCLC). Fine needle aspiration or sputum cytology will be used to obtain the samples.
Females of child – bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to enrolment in the study .
Performance status 2 of the Eastern Cooperative Oncology Group (ECOG) scale .
Measurable disease outside prior radiotherapy ports required , unless subsequent progression is documented .
Stable brain metastases .
Prior surgery or radiotherapy is allowed .
Age 18 years and over .
Life expectancy at least 12 weeks.
White Blood Cells (WBC) > 4.000/ml or platelets > 100.000/ml , bilirubin < 1.2 mg/dl, serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltranspeptidase, alkaline phosphatase (ALP) normal, creatinine < 1.4 mg/dl or creatinine clearance > 70 ml/min.
Informed consent has to be obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past or current history of neoplasm other than the entry diagnosis , except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix
Pregnant or nursing females or not practising adequate methods of contraception
Previous treatment with chemotherapy for recurrent or metastatic disease
Congestive heart failure . Documented myocardial infarction within the last 6 months
Pre – existing motor or sensory neurotoxicity grade > - 2 according to World Health Organization (WHO) criteria (intolerable paraesthesia and/or marked motor loss , or worse)
Unstable brain metastases
Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment , including prior allergic reactions to drugs containing cremophor , such as teniposide or cyclosporin .

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment outside Australia
Country [1] 2258 0
Greece
State/province [1] 2258 0

Funding & Sponsors
Funding source category [1] 243901 0
Other Collaborative groups
Name [1] 243901 0
Hellenic Cooperative Oncology Group
Country [1] 243901 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524, Athens
Country
Greece
Secondary sponsor category [1] 251244 0
None
Name [1] 251244 0
Address [1] 251244 0
Country [1] 251244 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a phase II randomized trial in an effort to compare two single agents Paclitaxel (Taxol) vs Vinorelbine (Navelbine) in poor performance Non-small cell lung cancer (NSCLC) patients .
The primary endpoint will be clinical benefit and the secondary response, toxicity, survival and time to progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30359 0
Address 30359 0
Country 30359 0
Phone 30359 0
Fax 30359 0
Email 30359 0
Contact person for public queries
Name 13606 0
Eleni Papakostaki
Address 13606 0
Hellenic Cooperative Oncology Group, 18, Hatzikostandi str, 11524, Athens
Country 13606 0
Greece
Phone 13606 0
+30 210 6912520
Fax 13606 0
Email 13606 0
[email protected]; [email protected]
Contact person for scientific queries
Name 4534 0
Paris Kosmidis
Address 4534 0
2nd Department of Medical Oncology, Hygeia Hospital, Kifisias Av & Er. Stavrou 4, 15123 Athens
Country 4534 0
Greece
Phone 4534 0
+30 210 6867105
Fax 4534 0
Email 4534 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.