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

September 28, 2017 updated by: NYU Langone Health

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Paclitaxel
Other Names:
  • Abraxane
Radiation: Radiation Therapy
Drug: Hormone Suppressors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks
Number of participants with qualitative and quantitative toxicities
Time Frame: up to 8 months
up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Nicholas Sanfilippo, MD, NYU Perlmutter Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9076 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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