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 |
| Protocol serial number | N/A |
| Sponsor | VU University Medical Centre (The Netherlands) |
| Funders | Eli Lilly (The Netherlands), Roche Nederland BV (The Netherlands) |
- 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
Contact information
Dr E F Smit
Scientific
Scientific
Vrije Universiteit Medical Centre (VUMC)
Department Pulmonary Diseases
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| ef.smit@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Pemetrexed, carboplatin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. To characterise the quantitative and qualitative toxicities of both regimens, response rates and duration of response for responding patients, and survival |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/01/2021: Publication reference added.
