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

Sponsor:	Beckman Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005857

Purpose

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	Intervention	Phase
Prostate Cancer	Biological: trastuzumab Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Trastuzumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2000

Detailed Description:

OBJECTIVES:

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.)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005857

Locations

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Massachusetts
St. Elizabeth's Medical Center of Boston
Brighton, Massachusetts, United States, 02135

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Primo N. Lara, MD

University of California, Davis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000067884, CHNMC-PHII-19, CHNMC-IRB-99118, NCI-T98-0090
Study First Received:	June 2, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005857 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents

Therapeutic Uses
Trastuzumab
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009