A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced NSCLC
- Conditions
- iet Kleincellig Long Carcinoom (NSCLC)
- Registration Number
- NL-OMON26799
- Lead Sponsor
- VALT/Vrije Universiteit Medical CentreAmsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method To characterize the quantitative and qualitative toxicities of both regimens, response rates and duration of response for responding patients, and survival. <br>2. Pharmacogenetic biomarker assessment