RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with erlotinib works in treating older patients with progressive prostate cancer that has not responded to hormone therapy.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer	Drug: docetaxel  Drug: erlotinib  Procedure: chemotherapy  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the response rate and response duration in older patients with progressive hormone refractory prostate cancer treated with docetaxel and erlotinib.

Secondary

• Determine the safety of this regimen in these patients.
• Evaluate the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Initial combination therapy: Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 3 additional courses beyond maximal response.
• Extension phase: After 9 courses of initial combination therapy, patients achieving a complete response, partial response, or stable disease receive 8 courses of erlotinib alone (total of 17 courses of study treatment). Quality of life is assessed at baseline, day 1 of each course, and at the end of study treatment. For patients in the extension phase, quality of life is also assessed on day 1 of courses 10, 12, 14, and 16.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 24 months.

Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Disease progression* after prior hormonal treatment with 1 of the following:
• Primary therapy, including 1 of the following:
• Orchiectomy
• Luteinizing hormone-releasing hormone (LHRH) antagonist** (e.g., abarelix)
• LHRH agonist** (e.g., leuprolide or goserelin) with or without an antiandrogen
• Patients must discontinue prior antiandrogen therapy AND have evidence of continued prostate-specific antigen (PSA) elevation (≥ 20% rise from baseline value) on ≥ 2 determinations taken ≥ 2 weeks apart
• More than 4 weeks since prior flutamide or megestrol
• More than 6 weeks since prior bicalutamide NOTE: **Patients previously treated with a LHRH agonist or antagonist instead of an orchiectomy must continue LHRH agonist or antagonist therapy during study participation in order to maintain castrate levels of testosterone
• Secondary therapy, including any of the following agents:
• Aminoglutethimide
• Ketoconazole
• Corticosteroids
• Diethylstilbestrol
• PC-SPES NOTE: *Disease progression is defined as at least 2 successive increases in serum PSA (≥ 20% rise from baseline value) taken ≥ 2 weeks apart AND serum testosterone level ≤ 50 ng/dL OR documented soft tissue or osseous progression
• PSA ≥ 20 ng/mL in patients without bidimensionally measurable disease or bone metastases
• Testosterone castrate levels (≤ 50 ng/dL)
• No brain metastases or clinical signs of brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age

• 65 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• WBC ≥ 2,800/mm^3
• Hemoglobin ≥ 8.0 g/dL

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)
• PT normal
• INR 0.7-1.5 (2.0-3.5 if on anticoagulation therapy)
• Meets 1 of the following criteria:
• Alkaline phosphatase ≤ 2.5 times ULN AND ALT/AST < 2.0 times ULN
• Alkaline phosphatase 2.6-3.9 times ULN AND ALT/AST < 1.5 times ULN
• Alkaline phosphatase ≥ 4.0 times ULN* AND ALT, AST, and bilirubin normal NOTE: *For patients with known bone involvement

Renal

• Creatinine ≤ 2.1 mg/dL

Cardiovascular

• No uncontrolled hypertension, defined as a resting blood pressure > 160/100 mmHg
• No clinical episodes of congestive heart failure
• No angina pectoris
• No myocardial infarction within the past year

Other

• Fertile patients must use effective contraception during and for 6 months after study participation
• No active infection requiring IV antibiotics
• No peripheral neuropathy > grade 1
• No prior severe hypersensitivity reaction to drugs formulated with polysorbate 80
• No other malignancy within the past 5 years except prostate cancer, nonmelanoma skin cancer, or carcinoma in situ of the bladder (stage T1a)

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 4 weeks since prior hormonal therapy for prostate cancer
• No concurrent hormonal therapy except androgen deprivation therapy and stable* regimens of prednisone or dexamethasone NOTE: *No change in medication or dosage within the past 2 weeks

Radiotherapy

• More than 4 weeks since prior radiotherapy
• More than 12 weeks since prior strontium chloride Sr 89, rhenium 186 hydroxyethylidene diphosphonate, or samarium Sm 153 lexidronam pentasodium
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• More than 4 weeks since prior major surgery

Other

• No concurrent prostata or saw palmetto
• No other concurrent experimental or commercial anticancer agents or therapies for the primary disease
• No other concurrent specific antitumor therapy for disease progression

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1738,  United States; Recruiting
      Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Washington
      University Cancer Center at University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States; Recruiting

Study chairs or principal investigators

Allan Pantuck, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000372833; UCLA-0308082; AVENTIS-GIA-16115; GENENTECH-OSI-2527S; NCT00087035
Record last reviewed:  June 2004
Last Updated:  March 10, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087035
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08