Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different
 ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs,
 such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and
 inner ear damage) caused by chemotherapy.

 PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together
 with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in
 treating patients with stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:

 Primary

 -  Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB
 or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without
 dimesna.

 -  Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment
 delays, in these patients.

 -  Compare the objective response rate in patients treated with these regimens.

 Secondary

 -  Compare the survival and failure-free survival of patients treated with these regimens.

 -  Compare the toxicity profile of these regimens in these patients.

 -  Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients
 treated with these regimens.

 OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
 arms.

 -  Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1
 and pegfilgrastim subcutaneously (SC) on day 2.

 -  Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and
 dimesna IV over 30 minutes on day 1.

 NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for
 hemoglobin ≤ 11 g/dL.

 In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of
 disease progression or unacceptable toxicity.

 Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
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