Clinical trial NCT00031187: Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
Official title: Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Prostate
Lewis Blood-Group System
Antibodies, Monoclonal
Antigens, Neoplasm
Antineoplastic Agents
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2002-02-28
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Los Angeles
country: United States
facility: West Los Angeles - VA Healthcare Center
state: California
city: Palo Alto
country: United States
facility: VA Medical Center of Palo Alto
state: California
city: San Diego
country: United States
facility: Sharp HealthCare, Sidney Kimmel Cancer Center
state: California
city: Greenwich
country: United States
facility: Bendheim Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Ft. Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Miami Shores
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
city: Arlington
country: United States
facility: Arlington Fairfax Hematology-Oncology, P.C.
state: Virginia
Study officials:
affiliation: Seagen Inc.
name: Andrew Sandler, MD
role: STUDY_DIRECTOR
References: