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Randomized Phase II Trial of Herceptin (NSC 688097) and Weekly Docetaxel (NSC 628503) in Androgen-Independent (Horomone Refractory) Adenocarcinoma of the Prostate (CaP)


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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 HopeDuarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
St. Elizabeth's Medical Center of BostonBrighton, Massachusetts  02135