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

NCT02911350 | Completed Phase 1

• 1 other identifier: 9076
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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)

  8 weeks

• Number of participants with qualitative and quantitative toxicities

  up to 8 months

Study Arms (1)

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.

Drug: Hormone Suppressors; Drug: Paclitaxel; Radiation: Radiation Therapy

Interventions

Hormone Suppressors DRUG

Hormone Suppressors, Paclitaxel & Radiation therapy

Paclitaxel DRUG

Also known as: Abraxane

Hormone Suppressors, Paclitaxel & Radiation therapy

Radiation Therapy RADIATION

Hormone Suppressors, Paclitaxel & Radiation therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinical stage T1N0, PSA \< 10, and Gleason score less than 7.
• Evidence of distant metastasis
• Previous surgery for prostate cancer (radical prostatectomy).
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• Nicholas Sanfilippo, MD

  NYU Perlmutter Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 22, 2016
• Study Start: May 1, 2000
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 2, 2017

Record last verified: 2017-09