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

NCT00916123 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 0812010139
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

castrate-resistant prostate cancer; CRPC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  completion of study treatment

Study Arms (5)

Dose Level 1

EXPERIMENTAL

177Lu-J591 at 20 mCi/dose

Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591

Dose Level 2

EXPERIMENTAL

177Lu-J591 at 25 mCi/dose

Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591

Dose Level 3

EXPERIMENTAL

177Lu-J591 at 30 mCi/dose

Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591

Dose Level 4

EXPERIMENTAL

177Lu-J591 at 35 mCi/dose

Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591

Dose Level 5

EXPERIMENTAL

177Lu-J591 at 40 mCi/dose

Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5

Prednisone DRUG

10 mg per day starting on cycle 1, day 1

Also known as: Meticorten, Sterapred, Sterapred DS

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5

177Lu-J591 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 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related 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 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.

  PMID: 32600929 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Scott Tagawa, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)