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

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Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

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

Gender: Male
Steward Physician(s)
  • Primo N. Lara, MD
Trial Interventions
Biological
  • trastuzumab
Drug
  • docetaxel
Physician Researcher

Investigator Name:

  • Primo N. Lara, MD

Other Information

Sponsor: City of Hope Medical Center
Phase: Phase 2
Trial ID: NCT00005857
Volunteers:  Not Accepting Healthy Volunteers

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