Anemia, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Neutropenia
Conditions
Keywords
drug/agent toxicity by tissue/organ, anemia, neutropenia, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, adenosquamous cell lung cancer
Brief 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.
Detailed 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.
Interventions
BIOLOGICALdarbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL
BIOLOGICALpegfilgrastim
6 mg sub Q day 2 of each cycle
DRUGcisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
DRUGdocetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
DRUGBNP7787
40 g IV over 30 min Day 1 of each cycle
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 12 weeks | Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity |
Secondary
| Measure | Time frame |
|---|---|
| Response | during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs |
| Survival | q 6 mon for 2 yrs after registration, then annually |
Countries
United States
Outcome results
None listed