Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 1439 for:    prostate cancer AND radiation

Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced 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: NCT00016913
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 29, 2016
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: carboplatin
Drug: estramustine
Drug: paclitaxel
Radiation: radiation therapy
Drug: leuprolide or goserelin acetate
Enrollment 34
Recruitment Details Between May 15, 2001 and June 30, 2006, a total of 34 patients were enrolled in the study. All CALGB institutions, comprised of 29 major university medical centers and their affiliates, were approved to participate in this study, of which 10 CALGB sites enrolled patients.
Pre-assignment Details Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.
Arm/Group Title Neo-Adj ChemoTx + Ablation Prior to RT
Hide Arm/Group Description Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title Neo-Adj ChemoTx + Ablation Prior to RT
Hide Arm/Group Description Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
61
(52 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
0
   0.0%
Male
27
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Toxicity
Hide Description Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy.
Time Frame 90 days and 1 year post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Final analyses were performed on all 27 eligible patients.
Arm/Group Title Neo-Adj ChemoTx + Ablation Prior to RT
Hide Arm/Group Description:
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Events
Grade 3+ Toxicity <=90 days post radiotherapy 2
Grade 3+ Toxicity >90 days post radiotherapy 0
2.Secondary Outcome
Title Time to Prostate-specific Antigen Failure
Hide Description PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.
Time Frame PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).
Hide Outcome Measure Data
Hide Analysis Population Description
All 27 evaluable patients were used in this analysis.
Arm/Group Title Neo-Adj ChemoTx + Ablation Prior to RT
Hide Arm/Group Description:
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
CALGB criteria
17.1
(13.3 to 25.9)
ASTRO criteria
12.1
(10.3 to 15.7)
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.
Time Frame registration to progression, up to 5.5 years from registration
Hide Outcome Measure Data
Hide Analysis Population Description
All 27 evaluable patients were used in this analysis
Arm/Group Title Neo-Adj ChemoTx + Ablation Prior to RT
Hide Arm/Group Description:
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
12.1
(10.3 to 15.7)
Time Frame [Not Specified]
Adverse Event Reporting Description All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
 
Arm/Group Title Neo-Adj ChemoTx + Ablation Prior to RT
Hide Arm/Group Description Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
All-Cause Mortality
Neo-Adj ChemoTx + Ablation Prior to RT
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Neo-Adj ChemoTx + Ablation Prior to RT
Affected / at Risk (%) # Events
Total   0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neo-Adj ChemoTx + Ablation Prior to RT
Affected / at Risk (%) # Events
Total   29/29 (100.00%)    
Blood and lymphatic system disorders   
Blood disorder  1  1/29 (3.45%)  1
Disseminated intravascular coagulation  1  1/29 (3.45%)  1
Hemoglobin decreased  1  27/29 (93.10%)  106
Hemolysis  1  2/29 (6.90%)  3
Transfusion: pRBCs  1  2/29 (6.90%)  2
Cardiac disorders   
Edema  1  14/29 (48.28%)  31
Left ventricular failure  1  2/29 (6.90%)  2
Sinus tachycardia  1  2/29 (6.90%)  2
Ear and labyrinth disorders   
Ear disorder  1  1/29 (3.45%)  1
Ear pain  1  1/29 (3.45%)  1
Tinnitus  1  1/29 (3.45%)  1
Endocrine disorders   
Endocrine disorder  1  3/29 (10.34%)  4
Eye disorders   
Diplopia  1  1/29 (3.45%)  1
Eye disorder  1  1/29 (3.45%)  1
Vision blurred  1  1/29 (3.45%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/29 (3.45%)  1
Abdominal pain  1  5/29 (17.24%)  9
Constipation  1  18/29 (62.07%)  27
Diarrhea  1  17/29 (58.62%)  36
Dry mouth  1  4/29 (13.79%)  4
Dyspepsia  1  6/29 (20.69%)  6
Fecal incontinence  1  1/29 (3.45%)  1
Flatulence  1  3/29 (10.34%)  3
Gastric hemorrhage  1  1/29 (3.45%)  1
Gastritis  1  1/29 (3.45%)  1
Gastrointestinal disorder  1  2/29 (6.90%)  2
Hemorrhoids  1  2/29 (6.90%)  3
Intra-abdominal hemorrhage  1  1/29 (3.45%)  1
Mucositis oral  1  5/29 (17.24%)  5
Nausea  1  17/29 (58.62%)  29
Proctitis  1  6/29 (20.69%)  9
Rectal bleeding/hematochezia  1  7/29 (24.14%)  9
Rectal hemorrhage  1  3/29 (10.34%)  3
Rectal pain  1  6/29 (20.69%)  12
Tooth disorder  1  1/29 (3.45%)  1
Vomiting  1  7/29 (24.14%)  9
General disorders   
Chest pain  1  2/29 (6.90%)  4
Fatigue  1  25/29 (86.21%)  102
Fever  1  4/29 (13.79%)  4
General symptom  1  1/29 (3.45%)  1
Ill-defined disorder  1  1/29 (3.45%)  1
Localized edema  1  1/29 (3.45%)  1
Pain  1  8/29 (27.59%)  21
Radiation-Other(Specify,_____)  1 [1]  1/29 (3.45%)  1
Infections and infestations   
Catheter related infection  1  1/29 (3.45%)  1
Infection without neutropenia  1  8/29 (27.59%)  10
Nail infection  1  1/29 (3.45%)  1
Sinusitis  1  1/29 (3.45%)  1
Urethral infection  1  1/29 (3.45%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/29 (3.45%)  1
Dermatitis radiation  1  2/29 (6.90%)  2
Investigations   
Activated partial thromboplastin time prolonged  1  9/29 (31.03%)  9
Alanine aminotransferase increased  1  11/29 (37.93%)  15
Alkaline phosphatase  1  1/29 (3.45%)  1
Alkaline phosphatase increased  1  1/29 (3.45%)  2
Aspartate aminotransferase increased  1  9/29 (31.03%)  22
Blood bilirubin increased  1  5/29 (17.24%)  6
Coagulopathy  1  1/29 (3.45%)  1
Creatine phosphokinase increased  1  2/29 (6.90%)  2
Creatinine increased  1  13/29 (44.83%)  24
Forced expiratory volume decreased  1  1/29 (3.45%)  1
INR increased  1  15/29 (51.72%)  17
Laboratory test abnormal  1  1/29 (3.45%)  4
Leukocyte count decreased  1  18/29 (62.07%)  58
Lymphocyte count decreased  1  9/29 (31.03%)  35
Neutrophil count decreased  1  10/29 (34.48%)  12
Platelet count decreased  1  15/29 (51.72%)  34
Serum cholesterol increased  1  1/29 (3.45%)  1
Weight gain  1  1/29 (3.45%)  2
Weight loss  1  1/29 (3.45%)  1
Metabolism and nutrition disorders   
Anorexia  1  9/29 (31.03%)  10
Blood bicarbonate decreased  1  2/29 (6.90%)  2
Blood glucose increased  1  23/29 (79.31%)  71
Blood uric acid increased  1  1/29 (3.45%)  2
Dehydration  1  2/29 (6.90%)  2
Serum albumin decreased  1  10/29 (34.48%)  23
Serum calcium decreased  1  14/29 (48.28%)  29
Serum calcium increased  1  3/29 (10.34%)  3
Serum glucose decreased  1  2/29 (6.90%)  3
Serum magnesium decreased  1  3/29 (10.34%)  5
Serum phosphate decreased  1  5/29 (17.24%)  6
Serum potassium decreased  1  4/29 (13.79%)  6
Serum potassium increased  1  4/29 (13.79%)  6
Serum sodium decreased  1  13/29 (44.83%)  24
Serum sodium increased  1  2/29 (6.90%)  2
Serum triglycerides increased  1  1/29 (3.45%)  2
Tumor lysis syndrome  1  1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/29 (20.69%)  6
Arthritis  1  2/29 (6.90%)  3
Back pain  1  4/29 (13.79%)  5
Bone pain  1  3/29 (10.34%)  5
Muscle weakness  1  1/29 (3.45%)  1
Muscle weakness lower limb  1  2/29 (6.90%)  2
Musculoskeletal disorder  1  4/29 (13.79%)  4
Myalgia  1  6/29 (20.69%)  9
Pain in extremity  1  1/29 (3.45%)  1
Nervous system disorders   
Dizziness  1  5/29 (17.24%)  7
Dysgeusia  1  7/29 (24.14%)  8
Extrapyramidal disorder  1  3/29 (10.34%)  3
Headache  1  7/29 (24.14%)  9
Neuralgia  1  1/29 (3.45%)  1
Neurological disorder NOS  1  1/29 (3.45%)  2
Peripheral motor neuropathy  1  3/29 (10.34%)  3
Peripheral sensory neuropathy  1  18/29 (62.07%)  57
Seizure  1  1/29 (3.45%)  1
Syncope  1  1/29 (3.45%)  1
Psychiatric disorders   
Anxiety  1  2/29 (6.90%)  2
Depression  1  2/29 (6.90%)  3
Insomnia  1  8/29 (27.59%)  11
Libido decreased  1  3/29 (10.34%)  4
Personality change  1  1/29 (3.45%)  1
Renal and urinary disorders   
Bladder spasm  1  1/29 (3.45%)  1
Cystitis  1  3/29 (10.34%)  4
Dysuria (painful urination)  1  14/29 (48.28%)  30
Hematuria (in the absence of vaginal bleeding)  1  9/29 (31.03%)  12
Incontinence  1  2/29 (6.90%)  2
Ureteric perforation  1  1/29 (3.45%)  1
Urinary frequency  1  26/29 (89.66%)  113
Urinary incontinence  1  1/29 (3.45%)  1
Urinary retention  1  6/29 (20.69%)  10
Urine discoloration  1  1/29 (3.45%)  1
Urogenital disorder  1  4/29 (13.79%)  5
Reproductive system and breast disorders   
Erectile dysfunction  1  13/29 (44.83%)  36
Gynecomastia  1  5/29 (17.24%)  16
Pelvic pain  1  1/29 (3.45%)  1
Penile pain  1  1/29 (3.45%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/29 (13.79%)  6
Dyspnea  1  5/29 (17.24%)  8
Dyspnea (shortness of breath)  1  14/29 (48.28%)  27
Epistaxis  1  9/29 (31.03%)  16
Hemoptysis  1  1/29 (3.45%)  1
Pharyngolaryngeal pain  1  1/29 (3.45%)  1
Pneumothorax  1  1/29 (3.45%)  1
Respiratory disorder  1  2/29 (6.90%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  8/29 (27.59%)  15
Dry skin  1  1/29 (3.45%)  1
Nail disorder  1  1/29 (3.45%)  1
Pruritus  1  3/29 (10.34%)  4
Rash desquamating  1  5/29 (17.24%)  12
Skin disorder  1  1/29 (3.45%)  1
Sweating  1  3/29 (10.34%)  3
Vascular disorders   
Flushing  1  1/29 (3.45%)  1
Hot flashes  1  13/29 (44.83%)  23
Hypertension  1  4/29 (13.79%)  5
Hypotension  1  2/29 (6.90%)  2
Phlebitis  1  2/29 (6.90%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
[1]
Swelling
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wm. Kevin Kelly, DO
Organization: Department of Medicine, Memorial Sloan-Kettering Cancer Center
EMail: kellyw@mskcc.org
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00016913     History of Changes
Other Study ID Numbers: CALGB-99811
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-99811
CDR0000068632 ( Registry Identifier: NCI Physician Data Query )
First Submitted: June 6, 2001
First Posted: January 27, 2003
Results First Submitted: July 31, 2015
Results First Posted: January 29, 2016
Last Update Posted: July 6, 2016