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A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis


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

Thank you

Trial Information

A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Arie Belldegrun, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000269889

NCT ID:

NCT00054574

Start Date:

November 2002

Completion Date:

February 2004

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111