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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL
6 mg sub Q day 2 of each cycle
75 mg/sq m IV over 1 hr Day 1 of each cycle
75 mg/sq m IV over 1 hr Day 1 of each cycle
40 g IV over 30 min Day 1 of each cycle
El Camino Hospital
Mountain View, California, United States
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Toxicity
Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
Time frame: 12 weeks
Response
Time frame: during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs
Survival
Time frame: q 6 mon for 2 yrs after registration, then annually
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