Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer

NCT00031187 | Completed Phase 2

• 1 other identifier: SG0001-015
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

Prostate; Lewis Blood-Group System; Antibodies, Monoclonal; Antigens, Neoplasm; Antineoplastic Agents

Interventions

SGN-15 (cBR96-doxorubicin immunoconjugate) DRUG

Taxotere (docetaxel) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (11)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

West Los Angeles - VA Healthcare Center

Los Angeles, California, 90073, United States

Location

VA Medical Center of Palo Alto

Palo Alto, California, 94304, United States

Location

Sharp HealthCare, Sidney Kimmel Cancer Center

San Diego, California, 92121, United States

Location

Bendheim Cancer Center

Greenwich, Connecticut, 06830, United States

Location

Broward Oncology Associates

Fort Lauderdale, Florida, 33308, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Innovative Medical Research of South Florida

Miami Shores, Florida, 33138, United States

Location

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 33308, United States

Location

Arlington Fairfax Hematology-Oncology, P.C.

Arlington, Virginia, 22205, United States

Location

Related Links

• Click here for more information about this study and the sponsor

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

BR96-doxorubicin immunoconjugate; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Andrew Sandler, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2002
• First Posted: February 28, 2002
• Study Start: October 1, 2000
• Study Completion: July 1, 2003
• Last Updated: October 24, 2011

Record last verified: 2011-10

Locations

US (11)