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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00916123
First received: June 5, 2009
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Drug: Prednisone
Drug: 177Lu-J591
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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. [ Time Frame: 4 weeks post last J591 dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591 [ Time Frame: completion of study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1
177Lu-J591 at 20 mCi/dose
Drug: Docetaxel
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
Other Name: Taxotere
Drug: Prednisone
10 mg per day starting on cycle 1, day 1
Other Name: Meticorten, Sterapred, Sterapred DS
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.
Experimental: Dose Level 2
177Lu-J591 at 25 mCi/dose
Drug: Docetaxel
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
Other Name: Taxotere
Drug: Prednisone
10 mg per day starting on cycle 1, day 1
Other Name: Meticorten, Sterapred, Sterapred DS
Drug: 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.
Experimental: Dose Level 3
177Lu-J591 at 30 mCi/dose
Drug: Docetaxel
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
Other Name: Taxotere
Drug: Prednisone
10 mg per day starting on cycle 1, day 1
Other Name: Meticorten, Sterapred, Sterapred DS
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.
Experimental: Dose Level 4
177Lu-J591 at 35 mCi/dose
Drug: Docetaxel
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
Other Name: Taxotere
Drug: Prednisone
10 mg per day starting on cycle 1, day 1
Other Name: Meticorten, Sterapred, Sterapred DS
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.
Experimental: Dose Level 5
177Lu-J591 at 40 mCi/dose
Drug: Docetaxel
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
Other Name: Taxotere
Drug: Prednisone
10 mg per day starting on cycle 1, day 1
Other Name: Meticorten, Sterapred, Sterapred DS
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916123

Contacts
Contact: Gina Mileo, R.N. 212-746-5430 gjm2003@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Gina Mileo, R.N.    212-746-5430    gjm2003@med.cornell.edu   
Principal Investigator: Scott Tagawa, M.D.         
Sub-Investigator: David Nanus, M.D.         
United States, North Carolina
University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Gayle Grigson, R.N.    919-966-4432 ext 240    ggrigson@med.unc.edu   
Principal Investigator: Young Whang, M.D.         
Sub-Investigator: William Kim, M.D.         
Sub-Investigator: Paul Godley, M.D.         
Sub-Investigator: Amir Khandani, M.D.         
Sub-Investigator: William McCartney, M.D.         
Sub-Investigator: Arif Sheikh, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Scott Tagawa, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Scott Tagawa, M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00916123     History of Changes
Other Study ID Numbers: 0812010139
Study First Received: June 5, 2009
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
castrate-resistant prostate cancer
CRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Prednisone
Docetaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014