Randomized Phase II Trial of Herceptin (NSC 688097) and Weekly Docetaxel (NSC 628503) in Androgen-Independent (Horomone Refractory) Adenocarcinoma of the Prostate (CaP)
18 Years
N/A
Male
Prostate Cancer
Trial Information
Randomized Phase II Trial of Herceptin (NSC 688097) and Weekly Docetaxel (NSC 628503) in Androgen-Independent (Horomone Refractory) Adenocarcinoma of the Prostate (CaP)
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.)
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Primo N. Lara, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, Davis
Authority:
United States: Federal Government
Study ID:
99118
NCT ID:
NCT00005857
Start Date:
August 2000
Completion Date:
October 2002
Related Keywords:
- Prostate Cancer
- stage IV prostate cancer
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| St. Elizabeth's Medical Center of Boston | Brighton, Massachusetts 02135 |
