Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00916123

Run by

Weill Medical College of Cornell University

People needed

15

Starts

2009-05-01

Expected to finish

2018-12-01

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Weill Cornell Medical College — New York, New York, United States
• University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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