This trial is active, not recruiting.

Condition prostate cancer
Treatments hormone suppressors, paclitaxel, radiation therapy
Phase phase 1
Sponsor New York University School of Medicine
Start date May 2000
End date June 2006
Trial size 24 participants
Trial identifier NCT02911350, 9076


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
hormone suppressors
paclitaxel Abraxane
radiation therapy

Primary Outcomes

Maximum tolerated dose (MTD) assessment
time frame: 8 weeks
Number of participants with qualitative and quantitative toxicities
time frame: up to 8 months

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
Principal investigator Nicholas Sanfilippo, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.