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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00031187

Collaborator

(none)

160

Enrollment

Locations

Duration (Months)

14.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: SGN-15 (cBR96-doxorubicin immunoconjugate) Drug: Taxotere (docetaxel)	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma

Study Start Date :

Oct 1, 2000

Actual Study Completion Date :

Jul 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center	Tucson	Arizona	United States	85724
2	Highlands Oncology Group	Springdale	Arkansas	United States	72764
3	West Los Angeles - VA Healthcare Center	Los Angeles	California	United States	90073
4	VA Medical Center of Palo Alto	Palo Alto	California	United States	94304
5	Sharp HealthCare, Sidney Kimmel Cancer Center	San Diego	California	United States	92121
6	Bendheim Cancer Center	Greenwich	Connecticut	United States	06830
7	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
8	Broward Oncology Associates	Ft. Lauderdale	Florida	United States	33308
9	Innovative Medical Research of South Florida	Miami Shores	Florida	United States	33138
10	St. Joseph Mercy Oakland Hospital	Pontiac	Michigan	United States	33308
11	Arlington Fairfax Hematology-Oncology, P.C.	Arlington	Virginia	United States	22205