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Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 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 Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > 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
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer,Drug Toxicity,Neutropenia,Anemia
Status: Not yet recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to compare the effectiveness of docetaxel and cisplatin with or without dimesna in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: 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. PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study within 18-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntoniusMiller, Study Chair, Comprehensive Cancer Center of Wake Forest University
Additional Information:
Study ID Numbers: CDR0000350089; CALGB-30303
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077311
Other Drug Toxicity Studies:
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4. Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome
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Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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