Back to resultsSafety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hormone Suppressors
Paclitaxel
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hormone Suppressors, Paclitaxel & Radiation therapy
Arm Description
Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months: Lupron / Flutamide Zoladex/ Flutamide Lupron/ Casodex 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.
Outcomes
Primary Outcome Measures
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)
Number of participants with qualitative and quantitative toxicities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02911350
Brief Title
Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer
Official Title
Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hormone Suppressors, Paclitaxel & Radiation therapy
Arm Type
Experimental
Arm Description
Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:
Lupron / Flutamide
Zoladex/ Flutamide
Lupron/ Casodex
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.
Intervention Type
Drug
Intervention Name(s)
Hormone Suppressors
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) assessment
Description
The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)
Time Frame
8 weeks
Title
Number of participants with qualitative and quantitative toxicities
Time Frame
up to 8 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Sanfilippo, MD
Organizational Affiliation
NYU Perlmutter Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer
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