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

NCT ID: NCT00031187

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2003-07-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SGN-15 (cBR96-doxorubicin immunoconjugate)

Intervention Type DRUG

Taxotere (docetaxel)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Andrew Sandler, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

West Los Angeles - VA Healthcare Center

Los Angeles, California, United States

Site Status

VA Medical Center of Palo Alto

Palo Alto, California, United States

Site Status

Sharp HealthCare, Sidney Kimmel Cancer Center

San Diego, California, United States

Site Status

Bendheim Cancer Center

Greenwich, Connecticut, United States

Site Status

Broward Oncology Associates

Fort Lauderdale, Florida, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Innovative Medical Research of South Florida

Miami Shores, Florida, United States

Site Status

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status

Arlington Fairfax Hematology-Oncology, P.C.

Arlington, Virginia, United States

Site Status

Countries

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United States

Related Links

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http://www.seattlegenetics.com

Click here for more information about this study and the sponsor

Other Identifiers

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SG0001-015

Identifier Type: -

Identifier Source: org_study_id

NCT00028470

Identifier Type: -

Identifier Source: nct_alias