Prostate CancerPhase 1NCT00916123
Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer
A Phase 1 study testing Docetaxel, Prednisone and 177Lu-J591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Docetaxel, Prednisone and 177Lu-J591
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Weill Cornell Medical College
New York, New York, 10021
About this study
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
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.
Read the 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
- Being tested
- Docetaxel, Prednisone, 177Lu-J591
- Keywords
- castrate-resistant prostate cancer, CRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle.
PrednisoneDrug
Also called Meticorten, Sterapred, Sterapred DS
10 mg per day starting on cycle 1, day 1
177Lu-J591Drug
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.
177Lu-J591Drug
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.
177Lu-J591Drug
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.
177Lu-J591Drug
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.
177Lu-J591Drug
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 group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 177Lu-J591 at 20 mCi/dose Receives: Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591 |
| Dose Level 2 | Experimental | 177Lu-J591 at 25 mCi/dose Receives: Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591 |
| Dose Level 3 | Experimental | 177Lu-J591 at 30 mCi/dose Receives: Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591 |
| Dose Level 4 | Experimental | 177Lu-J591 at 35 mCi/dose Receives: Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591 |
| Dose Level 5 | Experimental | 177Lu-J591 at 40 mCi/dose Receives: Drug: Docetaxel; Drug: Prednisone; Drug: 177Lu-J591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks post last J591 dose
Secondary outcomes (1)
Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591
Measured: completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2015
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Tagawa, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916123
- Sponsor's protocol ID
- 0812010139
- Status last verified
- May 2021
- First submitted
- 5 Jun 2009
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32600929
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00916123
- Acronym / sponsor ID
- 0812010139
- Conditions
- Prostate Cancer
- Keywords
- castrate-resistant prostate cancer, CRPC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: Docetaxel, Drug: Prednisone, Drug: 177Lu-J591177Lu-J591 at 20 mCi/dose |
| Dose Level 2 | Experimental | Drug: Docetaxel, Drug: Prednisone, Drug: 177Lu-J591177Lu-J591 at 25 mCi/dose |
| Dose Level 3 | Experimental | Drug: Docetaxel, Drug: Prednisone, Drug: 177Lu-J591177Lu-J591 at 30 mCi/dose |
| Dose Level 4 | Experimental | Drug: Docetaxel, Drug: Prednisone, Drug: 177Lu-J591177Lu-J591 at 35 mCi/dose |
| Dose Level 5 | Experimental | Drug: Docetaxel, Drug: Prednisone, Drug: 177Lu-J591177Lu-J591 at 40 mCi/dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere75 mg/m2 by intravenous infusion over one hour on day 1 of a 21 day cycle. | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5 |
| PrednisoneAlso: Meticorten, Sterapred, Sterapred DS10 mg per day starting on cycle 1, day 1 | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5 |
| 177Lu-J591Two 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 | Dose Level 1 |
| 177Lu-J591Two 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 | Dose Level 2 |
| 177Lu-J591Two 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 | Dose Level 3 |
| 177Lu-J591Two 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 | Dose Level 4 |
| 177Lu-J591Two 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. | Drug | Dose Level 5 |
Primary outcome
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
1 secondary outcome
Determine the toxicity profile of concurrent docetaxel with fractionated 177Lu-DOTA-J591
Time frame: completion of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Results publication: PubMed 32600929Batra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Tagawa, M.D. principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel, Prednisone and 177Lu-J591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.