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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005857
Recruitment Status : Completed
First Posted : August 29, 2003
Last Update Posted : October 20, 2011
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: trastuzumab Drug: docetaxel Phase 2

Detailed Description:


  • Compare the efficacy and toxicity of docetaxel (arm I) vs trastuzumab (Herceptin) (arm II), followed by a combination of docetaxel and trastuzumab in patients with androgen-independent or hormone-refractory metastatic, Her2/neu-positive prostate cancer. (Arm I closed to accrual effective 07/30/2001.)

OUTLINE: This is a multicenter study.

  • Arm I: Patients receive docetaxel IV over 1 hour weekly for 6 weeks. Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity. (Arm I closed to accrual effective 07/30/2001. Arm I patients crossover to arm II.)
  • Arm II: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity.

Patients with progressive or stable disease after 2 courses of single-agent therapy receive docetaxel IV over 1 hour on day 1 of each week for 6 consecutive weeks and trastuzumab IV over 30-90 minutes on day 1 of each week for 8 consecutive weeks. Treatment continues every 8 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients with complete or partial response to single-agent therapy continue on that therapy until experiencing progressive or stable disease. The patients then proceed to combination therapy.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 108-160 patients (54-80 per treatment arm) will be accrued for this study. (Arm I closed to accrual effective 07/30/2001.)

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Herceptin (NSC 688097) and Weekly Docetaxel (NSC 628503) in Androgen-Independent (Horomone Refractory) Adenocarcinoma of the Prostate (CaP)
Study Start Date : August 2000
Actual Primary Completion Date : October 2002
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 12 weeks


  • WBC at least 3,500/mm3
  • Absolute granulocyte count at least 1,800/mm3
  • Platelet count at least lower limit of normal (LLN)


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT no greater than 2 times ULN


  • Creatinine no greater than 1.6 mg/dL
  • Creatinine clearance at least 50 mL/min


  • 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


  • 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


Biologic therapy:

  • No concurrent biologic therapy


  • No more than one prior nonanthracycline chemotherapy regimen (including suramin)

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent corticosteroids as antiemetic


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005857

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United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Massachusetts
St. Elizabeth's Medical Center of Boston
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
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Study Chair: Primo N. Lara, MD University of California, Davis
Publications of Results:
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Responsible Party: City of Hope Medical Center Identifier: NCT00005857    
Other Study ID Numbers: 99118
U01CA063265 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000067884 ( Registry Identifier: NCI PDQ )
First Posted: August 29, 2003    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011
Keywords provided by City of Hope Medical Center:
stage IV prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological