A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Sponsors
Source
Jonsson Comprehensive Cancer Center
Oversight Info
Has Dmc
Yes
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.
Overall Status
Completed
Start Date
2002-11-01
Completion Date
2004-02-01
Primary Completion Date
2003-09-01
Phase
Phase 2
Study Type
Interventional
Condition
Intervention
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
Gender
Male
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Arie Belldegrun, MD, FACS |
Principal Investigator |
Jonsson Comprehensive Cancer Center |
Location
Facility |
|
Jonsson Comprehensive Cancer Center, UCLA Los Angeles California 90095-1738 United States |
|
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 United States |
Location Countries
Country
United States
Verification Date
2012-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
P30CA016042
UCLA-0206074
ABX-0301
Intervention Browse
Mesh Term
Panitumumab
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
February 5, 2003
Study First Submitted Qc
February 5, 2003
Study First Posted
February 6, 2003
Last Update Submitted
August 2, 2012
Last Update Submitted Qc
August 2, 2012
Last Update Posted
August 6, 2012
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.