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

NCT ID: NCT00916123

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2018-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dose Level 1

177Lu-J591 at 20 mCi/dose

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

10 mg per day starting on cycle 1, day 1

177Lu-J591

Intervention Type: DRUG

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.

Dose Level 2

177Lu-J591 at 25 mCi/dose

Group Type: EXPERIMENTAL

177Lu-J591

Intervention Type: DRUG

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.

Docetaxel

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

10 mg per day starting on cycle 1, day 1

Dose Level 3

177Lu-J591 at 30 mCi/dose

Group Type: EXPERIMENTAL

177Lu-J591

Intervention Type: DRUG

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.

Docetaxel

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

10 mg per day starting on cycle 1, day 1

Dose Level 4

177Lu-J591 at 35 mCi/dose

Group Type: EXPERIMENTAL

177Lu-J591

Intervention Type: DRUG

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.

Docetaxel

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

10 mg per day starting on cycle 1, day 1

Dose Level 5

177Lu-J591 at 40 mCi/dose

Group Type: EXPERIMENTAL

177Lu-J591

Intervention Type: DRUG

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.

Docetaxel

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

10 mg per day starting on cycle 1, day 1

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

Prednisone

10 mg per day starting on cycle 1, day 1

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Taxotere; Meticorten, Sterapred, Sterapred DS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Tagawa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32600929 (View on PubMed)

Other Identifiers

0812010139

Identifier Type: -

Identifier Source: org_study_id