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Hormone Therapy
Cabazitaxel + Radiation + Hormone Therapy for Prostate Cancer
Phase 1
Waitlist Available
Led By Robert Den, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly during imrt, then at 2 weeks and 3 months after imrt, and then every 3 months until 2 years after imrt
Awards & highlights
Study Summary
This trial is studying how well Cabazitaxel works when given with radiation therapy and androgen deprivation therapy in treating patients with prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly during imrt, then at 2 weeks and 3 months after imrt, and then every 3 months until 2 years after imrt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly during imrt, then at 2 weeks and 3 months after imrt, and then every 3 months until 2 years after imrt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally Tolerated Dose (MTD) of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT)
Secondary outcome measures
5-Year Biochemical Relapse Free Survival
Acute and Late Non-Hematologic and Hematologic Toxicity Profile of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT) Combination
Side effects data
From 2017 Phase 2 trial • 85 Patients • NCT0175717189%
Fatigue
47%
Abdominal pain
47%
Anemia
45%
Nausea
30%
Constipation
30%
Peripheral sensory neuropathy
26%
Diarrhea
26%
Anxiety
25%
Vomiting
25%
Dysphagia
23%
Hematuria
21%
Dyspnea
17%
Chills
17%
Edema limbs
17%
decreased WBC count
17%
Weight gain
15%
Gastroesophageal reflux disease
15%
Insomnia
13%
Bloating
13%
Depression
11%
Urinary frequency
11%
Neutropenia
11%
Cough
11%
Alopecia
9%
Paresthesia
9%
Hypertension
9%
Dysgeusia
9%
decreased platelets
8%
Abdominal distension
8%
Decreased white blood cell count
8%
Fever
8%
Thromboembolic event
8%
Sepsis
8%
Dizziness
8%
Malaise
6%
Dyspepsia
6%
Proteinuria
6%
Urinary tract infection
6%
Dry mouth
6%
decreseaed neutrophill count
6%
Neuropathy
6%
Hiccups
6%
Shortness of Breath
6%
Pain in extremity
6%
Anorexia
6%
HIGH ALKALINE PHOSPHATASE
6%
Acute kidney injury
4%
Abdominal Pain
4%
Hernia
4%
Dehydration
4%
H.Pylori Infection
4%
Dry skin
4%
Pneumonitis
4%
Colitis
4%
Palpitations
4%
Myelosuppression
4%
tachycardia
4%
Blurred vision
4%
Gastric hemorrhage
4%
Gastrointestinal pain
4%
Weakness
4%
Obesity
4%
Peripheral motor neuropathy
4%
Nocturia
4%
Hoarseness
4%
Vaginal hemorrhage
4%
increase mucus production
4%
Pleural effusion
4%
Headache
4%
Cold
4%
Early Satiety
4%
Weight Change
4%
Febrile neutropenia
4%
Non-cardiac chest pain
2%
extensive peritoneal carcinomatosis
2%
Epigastric discomfort
2%
Urinary retention
2%
Urinary incontinence
2%
Rib Pain (left side)
2%
Pain in anterior ribs
2%
increase sputum production
2%
Abdominal Tenderness
2%
Hypercholesterolemia
2%
oral thrush
2%
BRUISING
2%
Hypoxia
2%
right eye dimness
2%
decreased urine output
2%
Darkening of skin surrounding nasal areas
2%
arthralgia
2%
myalgia
2%
bone metastasis
2%
Flushing
2%
Hypercholesteremias
2%
sound in ear
2%
Hypothyroidism
2%
Right eye Pressure
2%
Right Upper Quadrant Pain
2%
biopsy site sore and numb
2%
Vitamin D deficiency
2%
hypercholesterolemia
2%
Diabetes
2%
Pneumonia
2%
peripheral vascular disease
2%
Syncope
2%
Gastric Hemorrhage
2%
Heart Block
2%
Hypokalemia
2%
Ascites
2%
Complete heart block
2%
Heart Disease (Organic)
2%
Hearing impaired
2%
Glaucoma
2%
erythema at the bottom of eyelids
2%
Esophageal fistula
2%
Gastric perforation
2%
Gastric ulcer
2%
Gastritis
2%
Mucositis oral
2%
Increased Eructation
2%
Heartburn
2%
Increasing Epigastric Pain
2%
Infusion related reaction
2%
uremia
2%
dehydration
2%
Itching
2%
HYPOALBUMINEMIA
2%
general discomfort
2%
Neuropathy to Extremities
2%
Swelling from Contrast Dye
2%
Discharge from Feeding Tube
2%
abdominal cramping
2%
Thrush
2%
Cholecystitis
2%
Elevate Liver Functions
2%
Splenic Vein Thrombosis
2%
mild jaundice
2%
Allergy to Penecillin
2%
pneumonia
2%
Elevated ANC
2%
Hyponatremia
2%
Hypophosphatemia
2%
vitamin B12 defeciency
2%
Iron defeciency
2%
Difficulty Feeding
2%
shallow white-based ulcer on L Lower buccal mucosa near border of lip
2%
reduced dexterity (right hand)
2%
brain metastases
2%
right arm spasms
2%
Stroke
2%
Altered Mental Status
2%
night sweats
2%
Hemoglobinuria
2%
Pyuria
2%
Dysuria
2%
overactive bladder
2%
renal failure
2%
increase in size of right testis
2%
post menopausal vaginal bleeding
2%
Aspiration
2%
Atelectasis
2%
Pulmonary embolism
2%
rales at the bases
2%
COPD exacerbation
2%
increased mucus
2%
Decreased breathing sounds over Left Lower Lung Field
2%
Postnasal drip
2%
Sleep apnea
2%
eczemarous dermatitis with eosinophilic folliculitis
2%
rosacia
2%
Chills/ Sweats
2%
psoriasis flare
2%
Skin Changes
2%
scatter petechiae
2%
portal vein thrombosis
2%
UROSEPSIS
2%
left ureteral stricture
2%
Pruritic maculaopapular rash LUQ
2%
bloody nose
2%
Puncture Wound Foot
2%
ecchymotic rash on hands
2%
Stomach pain
2%
mouth sore
2%
hiatus hernia syndrome
2%
epigastralgia
2%
Fall
2%
Vitamin D3 defeciency
2%
Lower extremity chills at night
2%
Tumor pain
2%
TINGLING IN HANDS
2%
vocal chord paralysis
2%
Hallucinations
2%
Apathy
2%
Esophageal pain
2%
Melena (black feces)
2%
Night Sweats
2%
right upper quadrant pain
2%
Urinary tract pain
2%
flu
2%
Lightheadedness
2%
Elevated CEA
2%
Flu like symptoms
2%
Infusion site extravasation
2%
Increased generalized weakness
2%
Pain
2%
Renal Failure
2%
Urinary Tract Obstruction
2%
Disseminated intravascular coagulation
2%
Leuocytosis
2%
Lymphadenopathy
2%
Left Neck Adenopathy
2%
Epistaxis (nose bleeds)
2%
vision change
2%
difficulty swallowing
2%
pyloric stenosis
2%
early satiety
2%
left upper quadrant pain
2%
bloody stools
2%
Localized edema
2%
Abrasion on R forearm after CT Scan
2%
hypersensitivity to oxaliplatin
2%
vasogenic edema
2%
BLE Edema
2%
moon face
2%
Hypocalcemia
2%
new left cervical and supraclavicular adenopathy of the axilla
2%
Brain Metastases
2%
Chronic kidney disease
2%
Cystitis noninfective
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Taxane naïve)
Arm B (Prior Taxane Therapy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)Experimental Treatment4 Interventions
Weekly Cabazitaxel with concurrent IMRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luteinizing Hormone-Releasing Hormone (LHRH) Agonist
2011
Completed Phase 1
~20
Bicalutamide
FDA approved
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~60
Cabazitaxel
FDA approved
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,460 Total Patients Enrolled
47 Trials studying Prostate Cancer
6,421 Patients Enrolled for Prostate Cancer
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,891 Total Patients Enrolled
12 Trials studying Prostate Cancer
1,547 Patients Enrolled for Prostate Cancer
Robert Den, MDPrincipal InvestigatorThomas Jefferson University
3 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Prostate Cancer
42 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction to Cabazitaxel or other medications that contain polysorbate 80.You have a history of diverticulitis, rectal bleeding, or other lower gastrointestinal diseases that can lead to complications after radiation treatment.You have received chemotherapy or radiation treatment in the past for cancer in the pelvis area.You are able to perform daily activities with a good level of energy and independence.
Research Study Groups:
This trial has the following groups:- Group 1: Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the safety outcomes of patients who have taken Cabazitaxel?
"Cabazitaxel has been assessed for safety and efficacy by our team at Power, receiving a mark of 1 due to its Phase 1 trial status. This implies limited clinical data is available that support the medication's security or effectiveness."
Answered by AI
Has Cabazitaxel undergone any previous research?
"At the moment, there are 16 Phase 3 studies of cabazitaxel underway out of 55 total trials. The majority are in Duarte, California; however, across the world there exist 4580 clinical trial sites studying this medication."
Answered by AI
Is this experimental trial unique in its approach?
"Currently, 55 Cabazitaxel trials are ongoing in 973 cities and 32 countries. AstraZeneca sponsored the initial trial which started back in 2000, involving 600 patients throughout its Phase 3 drug approval stage. Since then, 123 further studies have been conducted with respect to this medication."
Answered by AI
What is the participation rate for this experiment?
"Unfortunately, this clinical trial is not taking applications at the moment. It was first posted on September 22nd 2011 and last modified December 13th 2022. However, there are presently 1,326 studies for candidates with prostate cancer that are accepting participants as well as 55 trials actively seeking patients to take part in cabazitaxel therapy."
Answered by AI
Is the current research actively looking for participants?
"Unfortunately, this clinical trial is not currently recruiting participants. Its entry on clinicaltrials.gov was first created in September 2011 and amended last December 2022; however, 1381 other studies are still looking for patients presently."
Answered by AI
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