Niet Kleincellig Long Carcinoom (NSCLC)
Conditions
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
Sponsors
NVALT/Vrije Universiteit Medical Centre
Amsterdam
Eligibility
Inclusion criteria
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 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactE.F. Smit
Department of Pulmonary Diseases VU University Medical Centre PO Box 7057
Outcome results
None listed