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Sponsored by: |
Seattle Genetics, Inc. |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031603 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cBR96-doxorubicin immunoconjugate Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma |
Study Start Date: | October 2000 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or recurrent (unresectable) non-small cell lung carcinoma
Must have one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other primary malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 6 months since prior therapeutic or diagnostic murine/human chimeric antibodies or human monoclonal antibodies
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Oregon | |
Cancer Institute at Oregon Health and Science University | |
Portland, Oregon, United States, 97239-3098 |
Study Chair: | Dennis M. Miller, PhD, DABT | Seattle Genetics, Inc. |
Study ID Numbers: | CDR0000069080, SGEN-SG0002-015 |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00031603 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Recurrence Doxorubicin Carcinoma Antibodies, Monoclonal Docetaxel Antibodies |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Immunoconjugates Immunoglobulins Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Pharmacologic Actions |