Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

NCT00005857 | Completed Phase 2

• 7 other identifiers: 99118U01CA063265P30CA033572CHNMC-PHII-19CHNMC-IRB-99118NCI-T98-0090CDR0000067884
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of trastuzumab alone and in combination with docetaxel in treating patients who have metastatic prostate cancer that is refractory to hormone therapy.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Interventions

trastuzumab BIOLOGICAL

docetaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV prostate cancer (any T, any N, M1, any G; D3) * Clinical evidence of metastatic disease in bone or soft tissue * Her2/neu-positive (2+ and 3+) by immunochemistry or fluorescent in situ hybridization * Androgen-independent * Serum PSA at least 10 ng/mL that has risen on 3 successive evaluations after prior hormonal therapy * At least 1 month since prior antiandrogen therapy (e.g., flutamide, bicalutamide, or nilutamide) and rising PSA levels with 1 of the 2 rising PSA levels, measured at least 2 weeks apart, after antiandrogen withdrawal * Bone only disease and elevated PSA alone allowed * LHRH analog therapy must continue in patients who have not had prior orchiectomy and have castrate levels of testosterone PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,500/mm3 * Absolute granulocyte count at least 1,800/mm3 * Platelet count at least lower limit of normal (LLN) Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT no greater than 2 times ULN Renal: * Creatinine no greater than 1.6 mg/dL * Creatinine clearance at least 50 mL/min Cardiovascular: * Ejection fraction more than 50% or more than LLN by MUGA scan or 2-D echocardiogram * No symptomatic coronary artery disease * No active ischemia on EKG Other: * Fertile patients must use effective contraception * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * No more than one prior nonanthracycline chemotherapy regimen (including suramin) Endocrine therapy: * See Disease Characteristics * No concurrent corticosteroids as antiemetic Radiotherapy: * At least 4 weeks since prior radiotherapy * At least 3 months since prior strontium chloride Sr 89 and recovered * No concurrent radiotherapy to measurable lesions Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

St. Elizabeth's Medical Center of Boston

Brighton, Massachusetts, 02135, United States

Location

Related Publications (1)

• Lara PN Jr, Chee KG, Longmate J, Ruel C, Meyers FJ, Gray CR, Edwards RG, Gumerlock PH, Twardowski P, Doroshow JH, Gandara DR. Trastuzumab plus docetaxel in HER-2/neu-positive prostate carcinoma: final results from the California Cancer Consortium Screening and Phase II Trial. Cancer. 2004 May 15;100(10):2125-31. doi: 10.1002/cncr.20228.

  PMID: 15139054 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Trastuzumab; Docetaxel

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Primo N. Lara, MD

  University of California, Davis

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: August 29, 2003
• Study Start: August 1, 2000
• Primary Completion: October 1, 2002
• Study Completion: October 1, 2002
• Last Updated: October 20, 2011

Record last verified: 2011-10

Locations

US (4)