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Home > "S" Clinical Trials Conditions > Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer  Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
For Condition: Prostatic Neoplasms
Status: No longer recruiting
Sponsor(s): Seattle Genetics ,
Synopsis: SGN-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period.
Details: The purpose of this study is to evaluate a new class of biologic agent, the monoclonal antibody (mAb) drug conjugate SGN-15 (cBR96 - Doxorubicin immunoconjugate), used in combination with the taxane agent, TAXOTERE (docetaxel) as a strategy for targeting advanced stage, hormone refractory prostate carcinoma (HRPC). This is a randomized, open label, phase II study evaluating the immunoconjugate SGN-15 in combination with the taxane TAXOTERE in comparison to TAXOTERE alone in patients with HRPC. Based on a previous phase I study of the SGN-15/TAXOTERE combination, the weekly dose of SGN-15 will be 200 mg/m2 and the weekly dose of TAXOTERE will be 35 mg/m2. The schedule of administration for both agents will be weekly, with SGN-15 administered prior to the TAXOTERE in the patients treated with the combination. A single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks. The study will perform an interim analysis of the data after 80 patients have completed two courses. Patients should be treated for a minimum of 2 courses of therapy. Additionally, for patients who remain eligible and have experienced tolerable levels of drug toxicity, repeat dosing with subsequent cycles is possible. Patients will be removed from study if there is evidence of tumor progression or intolerable toxicity. Follow-up assessments include adverse event reporting, clinical laboratory studies, and quality of life (QOL) assessment using a validated QOL instrument.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: BRIEF: Patients must have pathologically confirmed prostate cancer, which is refractory to hormone therapy. There must be evidence of advancing disease, determined by increasing bidimensional or unidimensional measurable tumor or an increasing PSA with documented metastatic disease. Patients must have Lewis(Y) antigen expression documented by immunohistochemistry on archived or fresh tumor specimen.
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
AndrewSandler, Study Director, Seattle Genetics
Highlands Oncology Group
Springdale, Arkansas, 72764
United States
Arlington Fairfax Hematology-Oncology, P.C.
Arlington, Virginia, 22205
United States
VA Medical Center of Palo Alto
Palo Alto, California, 94304
United States
Sharp HealthCare, Sidney Kimmel Cancer Center
San Diego, California, 92121
United States
Bendheim Cancer Center
Greenwich, Connecticut, 06830
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
West Los Angeles - VA Healthcare Center
Los Angeles, California, 90073
United States
Innovative Medical Research of South Florida
Miami, Florida, 33138
United States
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 33308
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Broward Oncology Associates
Ft. Lauderdale, Florida, 33308
United States
Additional Information:
Study ID Numbers: SG0001-015;
Study Start Date: October 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031187
Other Prostatic Neoplasms Studies:
1. Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer
2. Study of a 6-Month Sustained-release Formulation of Leuprolide in Prostate Cancer
3. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
4. EPO906 Therapy in Patients with Prostate Cancer
5. A Phase III, Randomized Study of Atrasentan in Men with Non-Metastatic, Hormone-Refractory Prostate Cancer
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Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
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