Condition category
Cancer
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
11/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nvalt-oncology.nl

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 measures

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

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

http://www.vumc.nl/english/#http://www.vumc.nl/english/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes