Trastuzumab in Treating Patients With Prostate Cancer

NCT00003740 | Completed Phase 2

• 3 other identifiers: 98-085CDR0000066857NCI-G99-1493
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Interventions

trastuzumab BIOLOGICAL

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Howard I. Scher, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 3, 2004
• Study Start: October 1, 1998
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

US (1)