Non small cell lung cancer (NSCLC)
Conditions
Interventions
In arm 1 docetaxel will be administered at a dose of 75 mg/m2 as a one-hour i.v. infusion followed by carboplatin administered as a 30 min i.v. infusion on day 1 of each 3 week cycle. The carboplatin
Sponsors
UMCG
Department Pulmonary Diseases
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis of unresectable (stage III-b, pleuritis carcinomatosa) or disseminated (stage IV) NSCLS; 2. Age ≥ 18 years; 3. No prior chemotherapeutic treatment for NSCLC; 4. Measurable or evaluable tumor on physical examination, chest X-ray, CT-scan; 5. Performance status 0-2 (ECOG-score, see appendix 1); 6. Prior radiotherapy is allowed as long as no more than 25% of red bone marrow was irradiated. The irradiated area is not the only source of measurable disease; 7. Estimated life expectancy of at least 12 weeks; 8. Adequate bone marrow reserve: leukocytes ≥ 3,0 x 10^9/L, neutrophils ≥ 1,5 x 10^9/L, platelets 100 ≥ 10^9/L, and hemoglobin ≥ 6,2 mmol/L; 9. Adequate renal function (serum creatinine ≤ 130 µmol/L or creatinine clearance ≥ 60 ml/min); 10. Adequate liver function (total bilirubin ≤ UNL, ALAT/SGTP and ASAT/SGOT < 2,0 x UNL, alkaline phosphatase < 5,0 x UNL for the institution (UNL = Upper Normal Limit); 11. Patients of childbearing age should take medically approved contraceptive precautions during the trial and 3 months afterwards; 12. Patients must be able to comply with the scheduled visits; 13. Patients must give written informed consent before starting the study.
Exclusion criteria
Exclusion criteria: 1. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension, active infection or significant psychiatric illness; 2. Symptomatic brain metastases; 3. Patients with uncorrected hypercalcemia; 4. Patients with peripheral polyneuropathy grade ≥ 2 CTC Criteria; 5. Patients with a second primary malignancy except carcinoma in situ of the cervix or adequately treated basas cell carcinomas of the skin or adequately treated upper respiratory tract malignancies, disease-free more than 1 year after treatment; 6. ASAT and ALAT > 1,5 x UNL and alkaline phosphatase > 2,5 x UNL; 7. Patients who are pregnant or breast-feeding; 8. Participation in other trial with investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: 1. To assess efficary in terms of response rates, time to progression, duration of response and duration of palliation (appendix 5); 2. To evaluate toxic effects of treatment (CTC criteria, appendix 2); 3. To evaluate the effect of therapy on Quality of Life (appendix 5). | — |
Contacts
Public ContactH.J.M. Groen
University Medical Center Groningen (UMCG), Department of Pulmonary Disease, Box 30001
Outcome results
None listed