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Trial record 52 of 278 for:    prostate cancer AND localized | ( Map: United States )

Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer (NRR)

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: NCT00225420
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: docetaxel
Drug: leuprolide acetate
Radiation: radiation therapy
Enrollment 23
Recruitment Details Subjects with high-risk or locally advanced prostate cancer were recruited from 2 institutions between December 2005 and January 2010.
Pre-assignment Details Two patients were taken off the study due illness, two were removed because they were too large for the equipment, and one was removed due to CT screen failure.18 men with high-risk or locally advanced prostate cancer were enrolled. All 18 patients completed their radiation therapy and 16 completed all planned chemotherapy doses.
Arm/Group Title Docetaxel 10 mg/m2 Docetaxel 15 mg/m2 Docetaxel 20 mg/m2
Hide Arm/Group Description

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 centigray (cGy) in 200 cGy per fraction for a total of 39 treatments.

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments

Period Title: Overall Study
Started 9 6 3
Completed 9 6 3
Not Completed 0 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description

Single Arm Docetaxel: Docetaxel will be administered per the designated cohort starting at 10, 15 or 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
All patients included in this trial were high-risk localized (Gleason 8-10 or PSA level >= 20 ng/mL) prostate cancer, or T3 disease.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
62
(45 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  22.2%
White
14
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
Clinical Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
T1c-T2a
9
  50.0%
T2b-T2c
5
  27.8%
T3
4
  22.2%
[1]
Measure Description: The Classification of Malignant Tumours (TNM) system is a widely used cancer staging system. The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor. T0 means the main tumor cannot be found. The higher the number following T, the larger the tumor or the more it has grown.
Gleason Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Grade 7
3
  16.7%
Grade 8-10
15
  83.3%
[1]
Measure Description: A Gleason score is given based on how the prostate cancer tissue looks under the microscope. Gleason scores range from 2 to 10 and indicates how likely the tumor will spread. The higher the Gleason score the more likely the cancer tissue will spread.
PSA level, ng/mL   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<10 ng/mL
6
  33.3%
10-19 ng/mL
4
  22.2%
20-100 ng/mL
5
  27.8%
>100 ng/mL
3
  16.7%
[1]
Measure Description: Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in the blood. PSA levels are often elevated in men with prostate cancer.
1.Primary Outcome
Title Number of Patients Experiencing Dose-Limiting Toxicities
Hide Description Determine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.
Time Frame Average follow up of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel at 10 mg/m2 Docetaxel 15 mg/m2 Docetaxel 20 mg/m2
Hide Arm/Group Description:

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments

Overall Number of Participants Analyzed 9 6 3
Measure Type: Count of Participants
Unit of Measure: Participants
1 1 0
2.Secondary Outcome
Title Biochemical Progression-free Survival (PFS)
Hide Description Measure of the activity of a treatment on a disease. In this study it is measured from the date of enrollment to the date on which the prostate cancer progresses or the date the patient dies. Survival curves were estimated using the Kaplan-Meier technique. Biochemical (PSA) failure is defined, in accordance to the American Society for Therapeutic Radiology and Oncology consensus definition, as three consecutive rise in PSA. The date of biochemical failure is considered to be the midpoint between the last non-rising PSA and the first rising PSA.
Time Frame Average follow up of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.

Overall Number of Participants Analyzed 18
Mean (95% Confidence Interval)
Unit of Measure: percentage of patients
94
(65 to 99)
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description

Single Arm

docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm
Affected / at Risk (%)
Total   18/18 (100.00%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other (Specify, __) * 1 [1]  1/18 (5.56%) 
Hemoglobin * 1  12/18 (66.67%) 
Cardiac disorders   
Hypertension * 1  5/18 (27.78%) 
Pain - Chest/thorax NOS * 1  1/18 (5.56%) 
Supraventricular and nodal arrhythmia - Sinus tachycardia * 1  1/18 (5.56%) 
Endocrine disorders   
Hot flashes/flushes * 1  10/18 (55.56%) 
Gastrointestinal disorders   
Constipation * 1  6/18 (33.33%) 
Diarrhea * 1  8/18 (44.44%) 
Distension/bloating, abdominal * 1  3/18 (16.67%) 
Dry mouth/salivary gland (xerostomia) * 1  1/18 (5.56%) 
Flatulence * 1  1/18 (5.56%) 
Gastrointestinal - Other (Specify, __) * 1 [2]  1/18 (5.56%) 
Heartburn/dyspepsia * 1  2/18 (11.11%) 
Hemorrhage, GI - Abdomen NOS * 1  1/18 (5.56%) 
Hemorrhoids * 1  3/18 (16.67%) 
Incontinence, anal * 1  1/18 (5.56%) 
Nausea * 1  6/18 (33.33%) 
Pain - Abdomen NOS * 1  1/18 (5.56%) 
Pain - Rectum * 1  1/18 (5.56%) 
Pain - Stomach * 1  1/18 (5.56%) 
Proctitis * 1  1/18 (5.56%) 
Ulcer, GI - Anus * 1  1/18 (5.56%) 
Vomiting * 1  1/18 (5.56%) 
General disorders   
Constitutional Symptoms (Other, specify) * 1 [3]  1/18 (5.56%) 
Edema: head and neck * 1  1/18 (5.56%) 
Edema: limb * 1  1/18 (5.56%) 
Fatigue (asthenia, lethargy, malaise) * 1  11/18 (61.11%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 1  1/18 (5.56%) 
Flu-like syndrome * 1  1/18 (5.56%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever) * 1  1/18 (5.56%) 
Cytokine release syndrome/acute infusion reaction * 1  1/18 (5.56%) 
Infections and infestations   
Infection - Other (Specify, __) * 1 [4]  1/18 (5.56%) 
Investigations   
Alkaline phosphatase * 1  4/18 (22.22%) 
Leukocytes (total WBC) * 1  4/18 (22.22%) 
Lymphopenia * 1  12/18 (66.67%) 
Neutrophils/granulocytes (ANC/AGC) * 1  2/18 (11.11%) 
Platelets * 1  6/18 (33.33%) 
Weight gain * 1  2/18 (11.11%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) * 1  4/18 (22.22%) 
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  2/18 (11.11%) 
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  1/18 (5.56%) 
Bicarbonate, serum-low * 1  1/18 (5.56%) 
Bilirubin (hyperbilirubinemia) * 1  1/18 (5.56%) 
Calcium, serum-high (hypercalcemia) * 1  1/18 (5.56%) 
Cholesterol, serum-high (hypercholesteremia) * 1  1/18 (5.56%) 
Creatinine * 1  1/18 (5.56%) 
Glucose, serum-high (hyperglycemia) * 1  7/18 (38.89%) 
Magnesium, serum-high (hypermagnesemia) * 1  5/18 (27.78%) 
Phosphate, serum-low (hypophosphatemia) * 1  1/18 (5.56%) 
Potassium, serum-high (hyperkalemia) * 1  2/18 (11.11%) 
Potassium, serum-low (hypokalemia) * 1  1/18 (5.56%) 
Sodium, serum-low (hyponatremia) * 1  1/18 (5.56%) 
Triglyceride, serum-high (hypertriglyceridemia) * 1  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic) * 1  1/18 (5.56%) 
Musculoskeletal/Soft Tissue - Other (Specify, __) * 1 [5]  2/18 (11.11%) 
Pain - Back * 1  2/18 (11.11%) 
Pain - Joint * 1  1/18 (5.56%) 
Pain - Neck * 1  1/18 (5.56%) 
Pain - Other (Specify, __) * 1 [6]  1/18 (5.56%) 
Nervous system disorders   
Dizziness * 1  4/18 (22.22%) 
Neuropathy: sensory * 1  3/18 (16.67%) 
Pain - Head/headache * 1  3/18 (16.67%) 
Taste alteration (dysgeusia) * 1  2/18 (11.11%) 
Vasovagal episode * 1  1/18 (5.56%) 
Psychiatric disorders   
Insomnia * 1  7/18 (38.89%) 
Mood alteration - Anxiety * 1  2/18 (11.11%) 
Mood alteration - Depression * 1  1/18 (5.56%) 
Renal and urinary disorders   
Bladder spasms * 1  1/18 (5.56%) 
Pain - Bladder * 1  1/18 (5.56%) 
Renal/Genitourinary - Other (Specify, __) * 1 [7]  6/18 (33.33%) 
Urinary frequency/urgency * 1  14/18 (77.78%) 
Urinary retention (including neurogenic bladder) * 1  2/18 (11.11%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  1/18 (5.56%) 
Libido * 1  1/18 (5.56%) 
Pain - Penis * 1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Apnea * 1  1/18 (5.56%) 
Cough * 1  2/18 (11.11%) 
Dyspnea (shortness of breath) * 1  5/18 (27.78%) 
Pulmonary/Upper Respiratory - Other (Specify, __) * 1 [8]  2/18 (11.11%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) * 1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify, __) * 1 [9]  3/18 (16.67%) 
Dry skin * 1  1/18 (5.56%) 
Rash: acne/acneiform * 1  4/18 (22.22%) 
Skin breakdown/decubitus ulcer * 1  1/18 (5.56%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
decreased red blood cells
[2]
Gastroesophageal reflux disease (GERD).
[3]
Cold sensitivity
[4]
Cold Symptoms
[5]
leg cramps
[6]
Left shoulder
[7]
Dysuria; painful urination; intermittent bladder spasms
[8]
Cold/upper respiratory infection
[9]
Fungal infection
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin V. Johnson
Organization: Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: robin_v_johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00225420     History of Changes
Other Study ID Numbers: LCCC 0420
First Submitted: September 21, 2005
First Posted: September 23, 2005
Results First Submitted: March 9, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017