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SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical research trials and SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer. SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer clinical trial. Subjects typically recieve the finest healthcare available for their SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer  SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Seattle Genetics ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SGN-15 may be able to locate tumor cells and kill them without harming normal cells. Combining SGN-15 with docetaxel may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of metastatic or recurrent non-small cell lung cancer.
Details: OBJECTIVES: - Determine the toxicity and safety profile of SGN-15 (cBR96-doxorubicin immunoconjugate) in combination with docetaxel in patients with advanced or recurrent non-small cell lung carcinoma. - Determine the clinical response rate and response duration in patients treated with this regimen. - Determine the progression-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a randomized, open-label study. Patients are stratified according to gender and performance status. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive SGN-15 (cBR96-doxorubicin immunoconjugate) IV over 2 hours followed by docetaxel IV over 30 minutes once weekly on weeks 1-3 and 5-7. - Arm II: Patients receive docetaxel as in arm I. Quality of life is assessed at baseline and on day 1 of each course. Patients are followed at 8 weeks. PROJECTED ACCRUAL: A total of 60 patients (40 in arm I and 20 in arm II) will be accrued for this study within 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic or recurrent (unresectable) non-small cell lung carcinoma - Failed at least 1 but no more than 2 prior therapies for metastatic disease OR - Disease recurrence within 6 months of completing prior adjuvant chemotherapy - Lewis-Y antigen expression by immunohistochemistry - Must have one of the following: - Bidimensionally or unidimensionally measurable disease by physical exam or imaging studies - Evaluable disease, including bone metastases defined on bone scan OR malignant pleural effusion - No uncontrolled, symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Hemoglobin at least 10 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 2.5 times normal - Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis) - Amylase/lipase no greater than 1.5 times normal - No hepatic failure - No hepatitis B or C Renal: - Creatinine no greater than 1.5 times upper limit of normal - No renal failure Cardiovascular: - Left ventricular function at least 50% by echocardiogram or MUGA scan - No congestive heart failure Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to recombinant human or murine proteins - No peripheral neuropathy grade 2 or greater - No active viral, bacterial, or systemic fungal infections - No known HIV - No other primary malignancy except: - Non-melanoma skin cancer - Carcinoma in situ of the cervix - Localized prostate cancer - Completely resected stage I or II disease with no evidence of recurrence, from which patient has remained disease-free for more than 3 years - No uncontrolled significant non-malignant disease - No uncontrolled peptic ulcer disease - No serious underlying medical condition that would preclude study participation - No dementia or altered mental status that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 months since prior therapeutic or diagnostic murine/human chimeric antibodies or human monoclonal antibodies - Must be negative for BR96 antibodies in serum Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or anthracycline) - No prior docetaxel - Prior cumulative anthracycline exposure less than 300 mg/m^2 Endocrine therapy: - At least 4 weeks since prior hormonal therapy - No concurrent antineoplastic hormonal therapy, except estrogen replacement Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent anti-neoplastic agents - No other concurrent experimental agents - No concurrent immunosuppressive medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewSandler, Study Chair, Seattle Genetics
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
United States
Additional Information:
Study ID Numbers: CDR0000069080; SGEN-SG0002-015
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031603
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Paclitaxel in Treating Patients With Lung Cancer
2. R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
3. Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
4. Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
5. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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