A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

Date de début de l'étude : 1 août 2004

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed\* non-small cell lung cancer of 1 of the following subtypes: * Squamous carcinoma * Basaloid carcinoma * Adenocarcinoma * Bronchoalveolar carcinoma * Adenosquamous carcinoma * Large cell carcinoma * Large cell neuroendocrine carcinoma * Giant cell carcinoma * Sarcomatoid carcinoma * Non-small cell carcinoma not otherwise specified NOTE: \*Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection * Stage IIIB disease due to malignant pleural effusion OR stage IV disease * Measurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * The following are considered nonmeasurable disease: * Bone lesions * Brain metastases or leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions situated in a previously irradiated area * Brain metastases are allowed provided patient is neurologically stable and off steroids PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * AST ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ ULN Other * Not pregnant or nursing * Fertile patients must use effective contraception * No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent growth factors Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy * See Disease Characteristics * Prior radiotherapy allowed for brain metastases only * No concurrent palliative radiotherapy Surgery * See Disease Characteristics