Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer

NCT ID: NCT02911350

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31
• Study Completion Date: 2016-12-31

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hormone Suppressors, Paclitaxel & Radiation therapy

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.

Group Type: EXPERIMENTAL

Hormone Suppressors

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Radiation Therapy

Intervention Type: RADIATION

Interventions

Hormone Suppressors

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Radiation Therapy

Intervention Type: RADIATION

Other Intervention Names

Abraxane

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Sanfilippo, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Perlmutter Cancer Center

Other Identifiers

9076

Identifier Type: -

Identifier Source: org_study_id