Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr E F Smit
ORCID ID
Contact details
Vrije Universiteit Medical Centre (VUMC)
Department Pulmonary Diseases
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
ef.smit@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
NVALT-7 study
Study hypothesis
Is retreatment with platin based regimen in patients with recurrence of Non-Small Cell Lung Cancer (NSCLC) who failed platin based regimen in the first line more beneficial?
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Non Small Cell Lung Cancer (NSCLC)
Intervention
Experimental arm A:
Pemetrexed 500 mg/m^2 plus carboplatin Area Under the concentration–time Curve (AUC) 5 on day one every 21 days.
Control arm B:
Pemetrexed 500 mg/m^2 on day one every 21 days.
Intervention type
Drug
Phase
Phase II
Drug names
Pemetrexed, carboplatin
Primary outcome measure
To compare time to progression between single agent pemetrexed and pemetrexed-carboplatin in patients who failed previous cytotoxic treatment for NSCLC locally advanced and metastatic disease stage IIIB and IV.
Secondary outcome measures
1. To characterise the quantitative and qualitative toxicities of both regimens, response rates and duration of response for responding patients, and survival
2. Pharmacogenetic biomarker assessment
Overall trial start date
22/09/2005
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and IV, with evidence of disease progression after cytotoxic treatment which should have included a platinum agent
2. At least three months from prior chemotherapy with complete recovery from first line chemotherapy side effects to less than grade two
3. At least one unidimensionally measurable leasion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria
4. Eastern Cooperative Oncology Group (ECOG) performance status zero to two
5. Aged greater than 18 years
6. Adequate organ function, including:
a. adequate bone marrow reserve: Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L, platelets greater than 100 x 10^9/L
b. hepatic: bilirubin less than 1.5 x Upper Limit of Normal (ULN), Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) less than 3.0 x ULN. AP, ALT, and AST less than 5 x ULN is acceptable if the liver has tumour involvement
c. renal: calculated creatinine clearance greater than 45 ml/min based on the Cockroft and Gault formula
7. Signed informed consent
8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within seven days prior to study enrolment
9. Estimated life expectancy greater than 12 weeks
10. Patient compliance and geographical proximity that allow adequate follow up
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
230
Participant exclusion criteria
1. Pregnant or lactating women
2. Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection
3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrolment
4. Concomitant treatment with any other experimental drug under investigation
5. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a five-day period (eight day period for long-acting agents such as piroxicam)
6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone
Recruitment start date
22/09/2005
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije Universiteit Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Centre (The Netherlands)
Sponsor details
Department of Pulmonary Diseases
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Eli Lilly (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche Nederland BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list