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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02911350
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Hormone Suppressors Drug: Paclitaxel Radiation: Radiation Therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
Study Start Date : May 2000
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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: Hormone Suppressors
Drug: Paclitaxel
Other Name: Abraxane

Radiation: Radiation Therapy



Primary Outcome Measures :
  1. 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)

  2. Number of participants with qualitative and quantitative toxicities [ Time Frame: up to 8 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911350


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Nicholas Sanfilippo, MD NYU Perlmutter Cancer Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02911350     History of Changes
Other Study ID Numbers: 9076
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Paclitaxel
Albumin-Bound Paclitaxel
Hormones
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs