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Home > "S" Clinical Trials Conditions > Safety/Efficacy study of immunoconjugate with docetaxel in non-small cell lung carcinoma  Safety/Efficacy study of immunoconjugate with docetaxel in non-small cell lung carcinoma
Safety/Efficacy study of immunoconjugate with docetaxel in non-small cell lung carcinoma
For Condition: Carcinoma, Non-Small-Cell Lung
Status: No longer recruiting
Sponsor(s): Seattle Genetics ,
Synopsis: This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen. Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy. Lewis-y antigen expression documented by immunohistochemistry for all patients. Patients must have: * Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or * Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion Performance status 2 (ECOG scale) with a life expectancy of at least 3 months Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy) EXCLUSION CRITERIA: Prior therapy with TAXOTERE (docetaxel) Cumulative anthracycline exposure > 300 mg/m2. More than one primary malignancy with the exception of: * Non-melanoma skin cancer * In situ carcinoma of the cervix * Localized prostate cancer * Completely resected stage I or II disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years. Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure). Uncontrolled, symptomatic brain metastasis. Peripheral neuropathy > grade 2. Concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis. Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B or C. Women who are pregnant or breastfeeding Any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins. Dementia or altered mental status that would prohibit the understanding and rendering of informed consent. Patients with uncontrolled peptic ulcer disease will be excluded.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
AndrewSandler, Study Director, Seattle Genetics
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Virginia Mason Research Center
Seattle, Washington, 98101
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States
Bendheim Cancer Center
Greenwich, Connecticut, 06830
United States
Providence Health System
Portland, Oregon, 97213
United States
UCLA Medical Center
Los Angeles, California, 90095
United States
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, 34952
United States
Kaiser Permanente
Portland, Oregon, 97227
United States
University of Chicago
Chicago, Illinois, 60637
United States
Additional Information:
Study ID Numbers: SG0002-015;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051571
Other Carcinoma, Non-Small-Cell Lung Studies:
1. Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
2. Study of Temozolomide in the Treatment of Brain Metastasis from Non-small-cell Lung Cancer
3. A Phase 2 Trial of Antisense Nucleotide to PKC-alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients with Advanced, Previously Untreated Non-Small Cell Lung Cancer.
4. Utility of Anatometabolic Imaging for Radiation Treatment Planning for Lung Cancer
5. Erlotinib in Treating Patients with Advanced Non-Small Cell Lung Cancer
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Safety/Efficacy study of immunoconjugate with docetaxel in non-small cell lung carcinoma
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