Clinical trial NCT00054574: Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Official title: A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2003-02-06
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have prostate cancer that has not responded to hormone therapy.

Detailed description: OBJECTIVES:

* Determine the clinical effect of monoclonal antibody ABX-EGF, determined by the PSA response, in patients with hormone-resistant prostate cancer with rising PSA values without metastasis.
* Determine the pharmacokinetics and safety profile (including immunogenicity) of this drug in these patients.
* Determine the overall survival of patients treated with this drug.
* Determine the time to disease progression and time to PSA progression in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly. Treatment continues every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer with rising PSA values without metastasis

  * PSA must be at least 5 ng/mL
  * PSA must show an increase above a reference level on 2 separate occasions
* Must have tumor over-expressing epidermal growth factor receptor (EGFr) by immunohistochemistry

  * Staining must be 2+ or 3+ in at least 10% of evaluated tumor cells
  * Must have tissue available for diagnostics
* Must have failed prior front-line luteinizing hormone-releasing hormone (LHRH) analogue (e.g., leuprolide or goserelin) OR failed orchiectomy and have castrate levels of testosterone (less than 50 mg/mL) NOTE: Must continue on a LHRH analogue (unless an orchiectomy was performed) throughout the study

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 3 times ULN
* AST and ALT no greater than 3 times ULN

Renal

* Creatinine less then 2.2 mg/dL
* Calcium no greater than ULN

Cardiovascular

* Left ventricular ejection fraction at least 45% by MUGA
* No myocardial infarction within the past year

Other

* HIV negative
* Fertile patients must use effective contraception during and for 1 month after study
* No other malignancy within the past 5 years except basal cell carcinoma
* No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation, administration, or interpretation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* See Disease Characteristics
* At least 6 weeks since prior steroidal or nonsteroidal antiandrogens (4 weeks for flutamide)
* Concurrent steroid therapy allowed as replacement therapy only

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics

Other

* At least 30 days since prior investigational therapy
* At least 30 days since prior anticancer therapy
* No prior systemic therapy for prostate cancer (except hormonal therapy)
* No prior anti-EGFr therapy
* Concurrent antihypercalcemic treatment allowed in the presence of elevated calcium levels but not as cancer therapy for bone disease
* No other concurrent anti-EGFr therapy
* No other concurrent anticancer therapy
* No other concurrent investigational therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Arie Belldegrun, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: