Status:
COMPLETED
Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant prostate cancer.
Detailed Description
This research is being done because the standard treatments for metastatic prostate cancer that is growing despite medical or surgical therapies are not curative. Existing treatments, such as the doce...
Eligibility Criteria
Inclusion
- Histologic diagnosis of prostate adenocarcinoma.
- Patient must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy.
- Serum testosterone \< 50 mg/ml.
- Patients who have previously received docetaxel must meet BOTH of the the following criteria:
- reason for docetaxel discontinuation must NOT have been progression of disease while receiving drug (i.e. progression of cancer must have been AFTER docetaxel discontinuation) AND
- All docetaxel-related toxicities must have resolved to \< grade 1 (with the exception of alopecia) and the pt must be eligible by other criteria
Exclusion
- Use of red blood cell or platelet transfusions within 4 weeks of treatment.
- Use of hematopoietic growth factors within 4 weeks of treatment.-Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
- Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton ("superscan").
- Prior radiation therapy encompassing \>25% of skeleton.Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
- Platelet count \<150,000/mm3.
- Absolute neutrophil count (ANC) \<2,000/mm3.
- Hematocrit \<30 percent or Hemoglobin \< 10 g/dL.
- Abnormal coagulation profile (PT or INR, PTT) \> 1.3 x upper limit of normal (unless on therapeutic anticoagulation).
- -Serum creatinine \>2.5 mg/dL.
- AST (SGOT) \>2.5x ULN.
- Bilirubin (total) \>1.5x ULN.
- Serum calcium \>11 mg/dL.
- Active serious infection.
- Active angina pectoris or New York Heart Association Class III-IV.
- ECOG Performance Status \>2.
- Life expectancy \<6 months.
- Deep vein thrombosis and/or pulmonary embolus within 1 month of study entry.
- Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
- Prior anti-PSMA monoclonal antibody therapy with the exception of ProstaScint®.
- Prior investigational therapy within 6 weeks of treatment.
- Known history of HIV.
- Known history of myelodysplastic syndrome or leukemia
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00916123
Start Date
May 1 2009
End Date
December 1 2018
Last Update
May 20 2021
Active Locations (2)
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1
Weill Cornell Medical College
New York, New York, United States, 10021
2
University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599