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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Docetaxel

Prednisone

177Lu-J591

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring castrate-resistant prostate cancer, CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Weill Cornell Medical College
University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Dose Level 4

Dose Level 5

Arm Description

177Lu-J591 at 20 mCi/dose

177Lu-J591 at 25 mCi/dose

177Lu-J591 at 30 mCi/dose

177Lu-J591 at 35 mCi/dose

177Lu-J591 at 40 mCi/dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591

Full Information

NCT ID

NCT00916123

First Posted

June 5, 2009

Last Updated

May 17, 2021

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT00916123

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

May 2009 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

castrate-resistant prostate cancer, CRPC

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Level 1

Arm Type

Experimental

Arm Description

177Lu-J591 at 20 mCi/dose

Arm Title

Dose Level 2

Arm Type

Experimental

Arm Description

177Lu-J591 at 25 mCi/dose

Arm Title

Dose Level 3

Arm Type

Experimental

Arm Description

177Lu-J591 at 30 mCi/dose

Arm Title

Dose Level 4

Arm Type

Experimental

Arm Description

177Lu-J591 at 35 mCi/dose

Arm Title

Dose Level 5

Arm Type

Experimental

Arm Description

177Lu-J591 at 40 mCi/dose

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Meticorten, Sterapred, Sterapred DS

Intervention Description

10 mg per day starting on cycle 1, day 1

Intervention Type

Drug

Intervention Name(s)

177Lu-J591

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

177Lu-J591

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

177Lu-J591

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

177Lu-J591

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

177Lu-J591

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

4 weeks post last J591 dose

Secondary Outcome Measure Information:

Title

Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591

Time Frame

completion of study treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Tagawa, M.D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32600929

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.

Results Reference

result

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

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