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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00916123
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE June 5, 2009
First Posted Date  ICMJE June 9, 2009
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591 [ Time Frame: completion of study treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Dose Level 1
    177Lu-J591 at 20 mCi/dose
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: 177Lu-J591
  • Experimental: Dose Level 2
    177Lu-J591 at 25 mCi/dose
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: 177Lu-J591
  • Experimental: Dose Level 3
    177Lu-J591 at 30 mCi/dose
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: 177Lu-J591
  • Experimental: Dose Level 4
    177Lu-J591 at 35 mCi/dose
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: 177Lu-J591
  • Experimental: Dose Level 5
    177Lu-J591 at 40 mCi/dose
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: 177Lu-J591
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2009)
30
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00916123
Other Study ID Numbers  ICMJE 0812010139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Tagawa, M.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP