RANDOMIZED PHASE II TRIAL OF FIRST LINE CISPLATIN WITH DOCETAXEL OR VINORELBINE FOR 6 CYCLES IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG CANCER - CISPLATIN WITH DOCETAXEL OR VINORELBINE in NSCLC

• Conditions: PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG CANCER; MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2006-002934-40-IT
• Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of NSCLC; 2. Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC; 3. Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB only N3 supraclavicular or T4 for pleural effusion or Stage IV according to the revised International Staging System; 4. Patients must have at least one measurable lesion according to RECIST criteria. 5. Previous radical surgery more 30 days before study entry is allowed but a pathologic proof of progression of neoplastic disease must be documented; 6. Males or females aged between 18 and 70 years; 7. WHO Performance Status 0 or 1 Appendix I ; 8. Weight loss 5 within the last 3 months; 9. Laboratory requirements at entry - Blood cell counts Absolute neutrophils 2.0 . 109/L; Platelets 100 . 109/L; Hemoglobin 10 g/dl - Renal function Serum creatinine 1 upper normal limits UNL . In case of limit value of serum creatinine, the creatinine clearance should be 60 mL/min - Hepatic functions Serum bilirubin 1 x UNL; ASAT and ALAT 2.5 x UNL; Alkaline phosphatase 5 x UNL unless accompanied by extensive bone metastases 10. Obtained signed informed consent prior to start protocol specific requirements; 11. Patient compliance and geographic proximity that allow adequate follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior systemic chemotherapy or immunotherapy. Prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment; 2. Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy to 25 of the bone marrow is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiation therapy and the patient must have all side effects recovered. 3. Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer; 4. Patients with evaluable, not measurable disease only non target lesions ; 5. Patients with symptomatic brain metastases or with leptomeningeal disease; 6. History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years; 7. History of hypersensitivity reaction to polysorbate 80; 8. Pregnant or lactating women women of childbearing potential must use adequate contraception ; 9. Current peripheral neuropathy NCI grade 2; 10. Significant neurological or psychiatric disorders such as dementia that would prohibit them to understanding or rendering informed consent or from fully complying with treatment and follow-up; 11. Participation in clinical trials with other experimental agents within 30 days of study entry; 12. Other serious concomitant illness of medical conditions a Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia; b History of significant neurologic or psychiatric disorders including demential or seizures; c Active infection requiring iv antibiotics; d Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy; e Any other condition which in the judgement of the investigator would place the subject at undue risk or interfere with the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): To assess the antitumor activity and safety of vinorelbine given for six courses in combination with cisplatin versus docetaxel and cisplatin in combination..;Main Objective: To assess the antitumor activity and safety of vinorelbine given for six courses in combination with cisplatin versus docetaxel and cisplatin in combination..;Secondary Objective: To determine the time to progression, the time to treatment failure and the overall survival in each treatment arm. To evaluate the quantitative and qualitative aspects of safety in each treatment arm.