Clinical trial NCT00916123: Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer
Official title: A Phase I Trial of Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Anti-prostate-specific Membrane Antigen Monoclonal Antibody in Patients With Metastatic, Castrate-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: castrate-resistant prostate cancer
CRPC
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 docetaxel used as part of this study, may work temporarily, but unfortunately the cancer continues to grow. This test drug, 177Lu-J591, is designed to seek out prostate cancer cells and deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Determine the maximum tolerated dose of fractionated 177Lu-DOTA-J591 administered concurrently with three-weekly docetaxel for the treatment of patients with metastatic, castrate-resistant prostate cancer.
timeFrame: 4 weeks post last J591 dose
Secondary outcomes:
measure: Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591
timeFrame: completion of study treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Weill Medical College of Cornell University
name: Scott Tagawa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batra JS, Niaz MJ, Whang YE, Sheikh A, Thomas C, Christos P, Vallabhajosula S, Jhanwar YS, Molina AM, Nanus DM, Osborne JR, Bander NH, Tagawa ST. Phase I trial of docetaxel plus lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 (177Lu-J591) for metastatic castration-resistant prostate cancer. Urol Oncol. 2020 Nov;38(11):848.e9-848.e16. doi: 10.1016/j.urolonc.2020.05.028. Epub 2020 Jun 27.