Status:
COMPLETED
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. PURPOSE: This phase II ...
Detailed Description
OBJECTIVES: Primary * Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic disease
- Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters:
- New osseous lesions on bone scan
- Greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions OR the appearance of new lesions on MRI or CT scan
- Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy
- Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement
- PSA must be ≥ 5 ng/mL and ≥ 25% above the previous nadir
- Measurable or evaluable disease
- Serum testosterone ≤ 50 ng/dL
- No confluent lesions involving axial and appendicular skeleton on bone scan ("superscan")
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- Karnofsky 70-100%
- Life expectancy
- At least 6 months
- Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm\^3
- Hematocrit ≥ 30%
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 150,000/mm\^3
- No serious hematologic illness that would preclude study participation
- Hepatic
- AST ≤ 2 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- PTT normal
- PT normal OR
- INR normal
- No serious hepatic illness that would preclude study participation
- Renal
- Creatinine ≤ 2.5 mg/dL
- Calcium ≤ 11 mg/dL
- No serious renal illness that would preclude study participation
- Cardiovascular
- No New York Heart Association class III or IV heart disease
- No active angina pectoris
- No prior deep vein thrombophlebitis within the past 3 months
- No other serious cardiac illness that would preclude study participation
- Pulmonary
- No pulmonary embolus within the past 3 months
- No other serious respiratory illness that would preclude study participation
- Other
- Fertile patients must use effective contraception
- HIV negative
- No serious CNS illness that would preclude study participation
- No active serious infection not controlled by antibiotics
- No other serious illness that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 2 weeks since prior red blood cell or platelet transfusions
- More than 2 weeks since prior hematopoietic growth factors
- No prior monoclonal antibody therapy except ProstaScint®
- No other concurrent monoclonal antibody-based therapy
- No concurrent medication to support platelet count (e.g., oprelvekin)
- Chemotherapy
- More than 4 weeks since prior cytotoxic chemotherapy
- Endocrine therapy
- See Disease Characteristics
- Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true:
- Treatment is maintained during study participation
- Treatment is terminated at least 10 weeks (for 1-month depot preparations), 24 weeks (for 3-month depot preparations), or 32 weeks (for 4-month depot preparations) prior to study entry
- More than 4 weeks since prior corticosteroids
- More than 4 weeks since prior adrenal hormone inhibitors
- Concurrent low-dose prednisone (≤ 5mg/day) for adrenal insufficiency allowed
- No concurrent finasteride
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to \> 25% of skeleton
- No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium-containing compounds (e.g., Metastron® or Quadramet®)
- Surgery
- Not specified
- Other
- More than 4 weeks since prior PC-SPES
- More than 4 weeks since prior investigational therapy (medications or devices)
- At least 1 week since prior aspirin and/or nonsteroidal anti-inflammatory agents possessing antiplatelet activity
- At least 1 week since prior antiplatelet medication, including the following:
- Abciximab
- Cilostazol
- Clopidogrel
- Dipyridamole
- Ticlopidine
- No concurrent anticoagulant medications (for platelet count \< 50,000/mm\^3), including the following:
- Dalteparin
- Danaparoid
- Enoxaparin
- Heparin
- Warfarin
- No other concurrent investigational therapy
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00081172
Start Date
January 1 2004
End Date
May 1 2006
Last Update
July 10 2013
Active Locations (3)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
2
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
3
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032