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

Inclusion Criteria

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