Prostate CancerPhase 1NCT02911350
Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer
A Phase 1 study testing Hormone Suppressors, Paclitaxel and Radiation Therapy in people with Prostate Cancer, run by NYU Langone Health.
Trial summary
The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hormone Suppressors, Paclitaxel and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Dec 2016
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:
- Biopsy proven prostate cancer with Gleason score > 7
- Pathologic staging TXN1 (on MRI or CT)
- Prostate-specific antigen (PSA) > 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and > 10 days after prostate biopsy.
- In addition patients must also have:
- Performance status < 2
Show all 14Show fewer
- Hemoglobin > 11 grams per deciliter (g/dL), White blood cell (WBC) > 4000 and platelet count > 100.000/l
- No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free > 5 years.
- Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and
- Received hormone therapy with any of the following combination for less than 3 months
- Lupron / Flutamide
- Zoladex/ Flutamide
- Lupron/ Casodex
- Zoladex/ Casodex
Who cannot join
- Clinical stage T1N0, PSA < 10, and Gleason score less than 7.
- Evidence of distant metastasis
- Previous surgery for prostate cancer (radical prostatectomy).
- Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer
- Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.
- Bilirubin > 1.5
- Prior chemotherapy is not allowed
About this study
Official title: Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- Hormone Suppressors, Paclitaxel, Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone SuppressorsDrug
PaclitaxelDrug
Also called Abraxane
Radiation TherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hormone Suppressors, Paclitaxel & Radiation therapy | Experimental | Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:
1. Lupron / Flutamide
2. Zoladex/ Flutamide
3. Lupron/ Casodex
4. Zoladex/ Casodex
Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday \& Wednesday or Tuesday \& Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) \& 45 mg/m2 (dose level VI).
Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study. Receives: Drug: Hormone Suppressors; Drug: Paclitaxel; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) assessment
The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)
Measured: 8 weeks
Number of participants with qualitative and quantitative toxicities
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startMay 2000
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Sanfilippo, MD, Principal investigator, NYU Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911350
- Sponsor's protocol ID
- 9076
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT02911350
- Acronym / sponsor ID
- 9076
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Sep 2016 (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 determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormone Suppressors, Paclitaxel & Radiation therapy | Experimental | Drug: Hormone Suppressors, Drug: Paclitaxel, Radiation: Radiation TherapyHormone Suppressors: Patients may take any of the following combinations for a period of 6 months: 1. Lupron / Flutamide 2. Zoladex/ Flutamide 3. Lupron/ Casodex 4. Zoladex/ Casodex Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday \& Wednesday or Tuesday \& Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) \& 45 mg/m2 (dose level VI). Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:
- Biopsy proven prostate cancer with Gleason score > 7
- Pathologic staging TXN1 (on MRI or CT)
- Prostate-specific antigen (PSA) > 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and > 10 days after prostate biopsy.
- Performance status < 2
Key exclusion criteria (7 listed)
- Clinical stage T1N0, PSA < 10, and Gleason score less than 7.
- Evidence of distant metastasis
- Previous surgery for prostate cancer (radical prostatectomy).
- Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer
- Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.
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 |
|---|---|---|
| Hormone Suppressors | Drug | Hormone Suppressors, Paclitaxel & Radiation therapy |
| PaclitaxelAlso: Abraxane | Drug | Hormone Suppressors, Paclitaxel & Radiation therapy |
| Radiation Therapy | Radiation | Hormone Suppressors, Paclitaxel & Radiation therapy |
Primary outcome
Maximum tolerated dose (MTD) assessment
Time frame: 8 weeks
The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)
Number of participants with qualitative and quantitative toxicities
Time frame: up to 8 months
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 2 Oct 2017.
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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.
Nicholas Sanfilippo, MD principal investigator
NYU Perlmutter Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hormone Suppressors, Paclitaxel and Radiation Therapy in people with Prostate Cancer, run by NYU Langone Health.
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 14 inclusion and 7 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 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum tolerated dose (MTD) assessment (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2017.