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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916123
• Other study ID #: 0812010139
• Status: Completed
• Phase: Phase 1
• Start date: May 2009
• Est. completion date: December 2018

Study information

• Verified date: May 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
• Prednisone
10 mg per day starting on cycle 1, day 1
• 177Lu-J591
Two infusions of 177Lu-DOTA-J591 at 20 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
• 177Lu-J591
Two infusions of 177Lu-DOTA-J591 at 25 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
• 177Lu-J591
Two infusions of 177Lu-DOTA-J591 at 30 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
• 177Lu-J591
Two infusions of 177Lu-DOTA-J591 at 35 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.
• 177Lu-J591
Two infusions of 177Lu-DOTA-J591 at 40 mCi/dose will be given. The first infusion will be administered 2-3 days prior to docetaxel cycle 3. The second infusion will be administered two weeks later, i.e., day 13-15 of cycle 3.

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 antib — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 weeks post last J591 dose
Secondary	Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591		completion of study treatment