Cabazitaxel for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate CancerCabazitaxel - Drug
Eligibility
18+
Male
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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

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Weekly during IMRT, then at 2 weeks and 3 months after IMRT, and then every 3 months until 2 years after IMRT

Year 2
Acute and Late Non-Hematologic and Hematologic Toxicity Profile of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT) Combination
Year 2
Maximally Tolerated Dose (MTD) of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT)
Year 5
5-Year Biochemical Relapse Free Survival

Trial Safety

Side Effects for

Arm B (Prior Taxane Therapy)
70%Fatigue
48%Anemia
44%Nausea
35%Neutropenia
33%Vomiting
33%Abdominal pain
33%Diarrhea
30%Constipation
26%Peripheral sensory neuropathy
26%decreased WBC count
26%Edema limbs
22%Dyspnea
22%Abdominal distension
19%Insomnia
19%Anxiety
15%Cough
15%Dizziness
15%Hypotension
13%Decreased white blood cell count
11%Urinary frequency
11%decreseaed neutrophill count
11%Dyspepsia
11%Weight loss
11%Dysuria
9%Death
9%Thromboembolic event
7%Dry skin
7%Hematuria
7%Paresthesia
7%Lightheadedness
7%Weakness
7%generalized weakness
7%Alopecia
7%Hypertension
7%Dysphagia
7%Gastric hemorrhage
7%Flatulence
7%Increased Abdominal Girth
7%Fever
7%Depression
4%benign prostatic hypertrophy
4%Hydrouretroneprosis
4%renal failure
4%Nasal congestion
4%Acute Kidney Failure
4%Nodular findings
4%Hyperhidrosis
4%Hypohidrosis
4%Hyponatremia
4%Mycoplasma pneumoniae
4%Shortness of Breath
4%Allergic rhinitis
4%slow skin turgor
4%Headache
4%Renal Failure
4%Dysmenorrhea
4%urosepsis
4%Mouth ulcer
4%Loose Stools
4%Bacteremia
4%Ascites
4%Abdominal Pain
4%Increased generalized weakness
4%increased tears
4%Hypokalemia
4%Urinary Tract Obstruction
4%Myelosuppression
4%Urinary Tract Infection
4%Hypothyroidism
4%Gastrointestinal pain
4%mouth sore
4%Bloating
4%early satiety
4%Anasarca
4%Clostridium difficle
4%intermittent low appetite
4%Skin Changes
4%Edema- Scrotal
4%burping
4%Elevated CEA
4%Big white light and dizziness
4%Non-cardiac chest pain
4%Rigors
4%Body aches
4%Rash on Neck
4%Weight Change
4%hiatal hernia
4%cold intolerance
4%decreased absolute lymphocyte count
4%Bacteruria
4%Dysguesia
4%decreased platelets
4%Poor Oral Intake
4%Poor Appetite
4%Hypoalbuminemia
4%Decreased Appetite
4%hyperlipidemia
4%Bone Mets
4%Dysgeusia
4%hypersensitivity
4%Nocturia
4%UROSEPSIS
4%Difficulty Urinating
4%Hydronephrosis
4%Bengin enlargement of Prostate
4%Urinary tract obstruction
4%Hiccups
4%Epistaxis
4%VATS pleurodesis
4%Nail discoloration
4%Rash
4%flushing
4%easy bruisability
4%Acinetobacter baumanii bacteremia
4%balance difficulty
4%Prostatitis
4%Sore throat
4%Early Satiety
4%Pleural Effusion
4%Chills
4%neuropathy to fingers
4%Concentration impairment
4%Cystitis noninfective
4%Nephrolithiasis (Kidney Stone)
4%Localized edema
4%Malaise
4%decreased urine output
4%Stomach pain
4%Hypocalcemia
4%Gastric Hemorrhage
4%Dehydration
4%Rectal Obstruction
4%Cardiac arrest
4%Mucositis oral
4%Right Upper Quadrant Pain
4%Anal fissure
4%Sepsis
4%Positive blood culture
4%Allergic reaction
4%Agitation
4%Proteinuria
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT01757171) in the Arm B (Prior Taxane Therapy) ARM group. Side effects include: Fatigue with 70%, Anemia with 48%, Nausea with 44%, Neutropenia with 35%, Vomiting with 33%.

Trial Design

1 Treatment Group

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Cabazitaxel · No Placebo Group · Phase 1

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)Experimental Group · 4 Interventions: Luteinizing Hormone-Releasing Hormone (LHRH) Agonist, Anti-Androgen Therapy: Bicalutamide, Intensity Modulated Radiation Therapy (IMRT), Cabazitaxel · Intervention Types: Genetic, Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~40
Cabazitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weekly during imrt, then at 2 weeks and 3 months after imrt, and then every 3 months until 2 years after imrt

Who is running the clinical trial?

SanofiIndustry Sponsor
2,042 Previous Clinical Trials
2,959,130 Total Patients Enrolled
47 Trials studying Prostate Cancer
6,397 Patients Enrolled for Prostate Cancer
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
11,587 Total Patients Enrolled
12 Trials studying Prostate Cancer
2,303 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

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: