|- candidate number||2488|
|- NTR Number||NTR916|
|- Date ISRCTN created||11-apr-2007|
|- date ISRCTN requested||24-mrt-2007|
|- Date Registered NTR||22-feb-2007|
|- Secondary IDs||N/A |
|- Public Title||A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced NSCLC|
|- Scientific Title||A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced NSCLC|
|- ACRONYM||NVALT-7 study|
|- hypothesis||Is retreatment with platin based regimen in patients with recurrence of NSCLC who failed platin based regimen in the first line more beneficial. |
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC)|
|- 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 3 months from prior chemotherapy with complete recovery from first line chemotherapy side effects to < Grade 2
3.At least one unidimensionally measurable leasion meeting RECIST criteria.
4.ECOG PS 0-2
5.Age > 18 years
6.Adequate organ function, including:
a.Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
b.Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 3.0 x ULN AP, ALT, and AST <5 xULN is acceptable if the liver has tumor involvement
c.Renal: calculated creatinine clearance > 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 7 days prior to study enrollment.
9.Estimated life expectancy >12 weeks
10. Patient compliance and geographical proximity that allow adequate follow up.
|- 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 enrollment.
4.Concomitant treatment with any other experimental drug under investigation.
5.Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8 day period for long-acting agents such as piroxicam).
6.Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||22-sep-2005|
|- planned closingdate||1-jan-2008|
|- Target number of participants||230|
|- Interventions||Experimental Arm A:. pemetrexed 500 mg/m2 plus carboplatin AUC 5 on Day 1 every 21 days.
Control Arm B: pemetrexed 500 mg/m2 on Day 1 every 21 days
|- Primary outcome||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||To characterize the quantitative and qualitative toxicities of both regimens, response rates and duration of response for responding patients, and survival.
2. Pharmacogenetic biomarker assessment|
|- Trial web site||http://www.nvalt-oncology.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. MD. PhD. E.F. Smit |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. MD. PhD. E.F. Smit |
|- Sponsor/Initiator ||VU University Medical Centre, Department Pulmonary Diseases|
(Source(s) of Monetary or Material Support)
|Eli Lilly Nederland B.V., Roche Nederland BV|
|- Brief summary||The standard treatment for patients with a recurrence of the NSCLC and a good performance score after treatment with chemotherapy is single agent docetaxel. Recently, pemetrexed is registered for this indication, based on a phase III study. The study showed that the survival is comparable with those who obtained with docetaxel, the toxicity of pemetrexed was significantly less. One of the questions with patients with recurrence of NSCLC after failure of first-line with platin based regimen is whether a retreatment with platin combination is more beneficial. Primary objective is 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. The secondary objective is to characterize the quantitative and qualitative toxicities of both regimens, response rates and duration of response for responding patients, and survival. patients will be randomized for treatment with pemetrexed 500 mg/m2 of treatment with carboplatin AUC5 and pemetrexed 500 mg/m2. Treatments will be administered every 21 days, 4 cycles. All patients will be treated with vitamine B12 and folic acid. The most important in- and exclusion criteria are: cytologically or histologically advanced non small cell lungcancer, stage IIIb and IV, progression after treatment with a platinum agent, performance score 0-2, >18 years, adequate bone narrow reserve, adequate liver and kidney function, measureable lesion meeting RECIST criteria. Excluded are patients with severe co-morbidity, active infection and symptomatic brainmetastasis.
The number of patients required for this trial is 230, 115 in each arm, with a power of 80% to detect a difference of 33% in the progression free survival.
|- Main changes (audit trail)|
|- RECORD||22-feb-2007 - 12-apr-2007|