Trastuzumab in Treating Patients With Prostate Cancer

June 20, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase II Study of Herceptin (Recombinant Humanized Anti-p185HER2 Monoclonal Antibody) for the Treatment of Androgen Independent Prostate Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have prostate cancer that has not responded to hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Assess the activity of trastuzumab (Herceptin) in patients with progressive androgen dependent and independent prostate cancer. II. Study HER2 status by immunohistochemistry on prostate cancer biopsy samples. III. Study associations between HER2 protein expression on tumor cells and post-therapy changes in PSA in this patient population.

OUTLINE: Patients receive trastuzumab IV over 30 or 90 minutes once a week. Treatment continues for a maximum of 24 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed for time to progression.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 6-9 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically documented androgen dependent or independent prostate cancer Progressive disease on primary hormonal treatment (e.g., orchiectomy, estrogen therapy, gonadotropin releasing hormone analog with or without an antiandrogen) New osseous lesions by bone scan OR 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by MRI or CT scan If initial hormonal treatment was a combined androgen blockade approach, must show progression off of the antiandrogen Minimum of 3 rising PSA values from baseline obtained 1 week or more apart OR 2 rising PSA values obtained 2 or more weeks apart PSA at least 4 ng/mL Testosterone no greater than 30 ng/mL No active CNS or epidural tumor

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times upper limit of normal PT less than 14 seconds Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the prior 6 months No active angina pectoris, New York Heart Association class III or IV heart disease, or severe debilitating valvular disease Ejection fraction greater than 45%, with no evidence of ventricular aneurysm or other abnormal wall motion OR SESTAMIBI stress test must show fixed defect alone if ejection fraction less than 45%, or a worrisome but nonexclusive cardiovascular history, or an abnormal ECG Pulmonary: No severe pulmonary disease Other: Fertile patients must use effective contraception No history of an active secondary malignancy with the past 5 years except nonmelanoma skin cancer No infection requiring intravenous antibiotic treatment No other severe medical problem that would increase the risk for toxicity

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics If no prior surgical orchiectomy, must continue medical therapies to maintain castrate levels of testosterone Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics and Endocrine therapy No concurrent surgery Other: At least 4 weeks since other prior investigational anticancer therapeutic drugs and recovered No prior anthracycline or anthracenedione No concurrent investigational or unlicensed agents No other concurrent oncolytic agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

September 1, 2002

Study Completion (Actual)

September 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 2, 2004

First Posted (Estimate)

June 3, 2004

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-085
  • CDR0000066857 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G99-1493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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