A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced non-small cell lung cancer

ISRCTN	ISRCTN38269072
DOI	https://doi.org/10.1186/ISRCTN38269072
Secondary identifying numbers	N/A

Submission date: 11/04/2007
Registration date: 11/04/2007
Last edited: 05/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr E F Smit
Scientific

Vrije Universiteit Medical Centre (VUMC)
Department Pulmonary Diseases
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Email	ef.smit@vumc.nl

Study information

Study design	Randomised, active controlled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced non-small cell lung cancer
Study acronym	NVALT-7 study
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	22/09/2005
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	230
Key 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
Key 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
Date of first enrolment	22/09/2005
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije Universiteit Medical Centre (VUMC)

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Pulmonary Diseases
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Website	http://www.vumc.nl/english/#http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Industry

Eli Lilly (The Netherlands)

No information available

Roche Nederland BV (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2016	04/01/2021	Yes	No

Editorial Notes

04/01/2021: Publication reference added.