Lung Cancer Clinical Trial
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Summary
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.
Full Description
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.
Eligibility 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
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There are 57 Locations for this study
Mountain View California, 94040, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Wilmington Delaware, 19805, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Bettendorf Iowa, 52722, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
Elkton MD Maryland, 21921, United States
Saint Louis Missouri, 63141, United States
St. Louis Missouri, 63131, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
Hooksett New Hampshire, 03106, United States
Laconia New Hampshire, 03246, United States
Manchester New Hampshire, 03103, United States
Voorhees New Jersey, 08043, United States
Glens Falls New York, 12801, United States
Syracuse New York, 13057, United States
Syracuse New York, 13210, United States
Syracuse New York, 13215, United States
Utica New York, 13502, United States
Durham North Carolina, 27710, United States
Goldsboro North Carolina, 27534, United States
Kinston North Carolina, 28501, United States
Wilmington North Carolina, 28401, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73120, United States
Florence South Carolina, 29501, United States
Dallas Texas, 75216, United States
Dallas Texas, 75235, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Huntington West Virginia, 25702, United States
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