Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
NCT00054574CI-TRIAL-00046346completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| panitumumab | Biological | Panitumumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.