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Anti-tumor antibiotic

CGC Therapy for Bladder Cancer (CGC Trial)

Phase 1 & 2
Waitlist Available
Led By Guarionex DeCastro, MD
Research Sponsored by Guarionex J. Decastro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All grossly visible disease in the bladder must be fully resected and pathologic stage will be confirmed at the study institution
Patients must have a histologically confirmed diagnosis of non-muscle invasive urothelial carcinoma of the bladder at the study institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks from baseline
Awards & highlights

CGC Trial Summary

This trial is testing a new combination of drugs to treat bladder cancer that has not responded to other treatments. The goal is to find the highest dose of the drugs that can be given without causing serious side effects. Up to 24 patients will be enrolled.

Who is the study for?
This trial is for adults over 18 with non-muscle invasive bladder cancer resistant to BCG therapy. They must be eligible for but not wanting or able to undergo radical cystectomy, have an ECOG status of 0 or 1, and agree to use effective contraception. Exclusions include severe drug allergies, recent participation in other trials, certain treatments within the last 6 weeks, concurrent cancers or chemotherapy, and inadequate organ function.Check my eligibility
What is being tested?
The study tests a new combination of drugs (Cabazitaxel, Gemcitabine, Cisplatin) given directly into the bladder for those whose bladder cancer hasn't responded to standard treatment. Up to 24 patients will join this phase I trial which aims to find out how safe the treatment is and what dose is best.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to drug sensitivity; issues affecting blood cells leading to increased infection risk; kidney problems from Cisplatin; fatigue; hair loss from Cabazitaxel; and sores in mouth or digestive tract issues from Gemcitabine.

CGC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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All visible bladder cancer has been surgically removed and its stage confirmed.
Select...
My bladder cancer is confirmed and not spread into the muscle.
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My cancer came back after standard bladder treatment.
Select...
My bladder cancer has not responded to BCG treatment or has come back.
Select...
My condition worsened within 18 months after my last BCG treatment.
Select...
I haven't received any clinical trial treatments in the last 6 weeks.
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I am eligible for but refusing or cannot undergo major bladder surgery due to other health issues.
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I am capable of becoming pregnant and have a negative pregnancy test.
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I haven't had experimental bladder treatments in the last 6 weeks.
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I am mostly active and can care for myself, even if I can't have surgery due to other health issues.
Select...
I am over 18 and can understand and sign the consent form.

CGC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1a/1b: The number of serious adverse events associated with therapy of intravesically administered Cabazitaxel, Gemcitabine, and Cisplatin.
Phase 2: The number of complete responders after completion of six weeks of intravesically
Secondary outcome measures
The number of complete responders after completion of six weeks of intravesically administered Cabazitaxel, Gemcitabine, and Cisplatin.

Side effects data

From 2017 Phase 2 trial • 85 Patients • NCT01757171
89%
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%
Decreased white blood cell count
8%
Abdominal distension
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%
Dehydration
4%
Hernia
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%
Urinary incontinence
2%
increase sputum production
2%
extensive peritoneal carcinomatosis
2%
Pain in anterior ribs
2%
Hypercholesterolemia
2%
Epigastric discomfort
2%
Abdominal Tenderness
2%
oral thrush
2%
BRUISING
2%
Rib Pain (left side)
2%
Urinary retention
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)

CGC Trial Design

5Treatment groups
Experimental Treatment
Group I: Gem, High Cab, and Low CisExperimental Treatment3 Interventions
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 66mg/100ml; 1 time a week for 6 weeks; 2 hours
Group II: Gem, High Cab, Mod CisExperimental Treatment3 Interventions
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 80mg/100ml; 1 time a week for 6 weeks; 2 hours
Group III: Gem, High Cab, High CisExperimental Treatment3 Interventions
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours Cisplatin: Intravesical; 100mg/100ml; 1 time a week for 6 weeks; 2 hours
Group IV: Gem and Low CabExperimental Treatment2 Interventions
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 2.5mg/100ml; 1 time a week for 6 weeks; 2 hours
Group V: Gem and High CabExperimental Treatment2 Interventions
Gemcitabine: Intravesical; 2000mg/100ml; 1 time a week for 6 weeks; 2 hours Cabazitaxel: Intravesical; 5mg/100ml; 1 time a week for 6 weeks; 2 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Cabazitaxel
2014
Completed Phase 3
~1290

Find a Location

Who is running the clinical trial?

Guarionex J. DecastroLead Sponsor
James M. McKiernanLead Sponsor
SanofiIndustry Sponsor
2,158 Previous Clinical Trials
3,514,297 Total Patients Enrolled

Media Library

Cabazitaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02202772 — Phase 1 & 2
Bladder Cancer Research Study Groups: Gem and Low Cab, Gem and High Cab, Gem, High Cab, and Low Cis, Gem, High Cab, Mod Cis, Gem, High Cab, High Cis
Bladder Cancer Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT02202772 — Phase 1 & 2
Cabazitaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02202772 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic benefits does Cabazitaxel offer?

"Cabazitaxel is a therapeutic agent used to treat neoplasm metastasis, advance directives, and urinary bladder dysfunction."

Answered by AI

Is this research protocol open to participants at the moment?

"Clinicaltrials.gov reveals that this clinical trial is actively recruiting individuals since it was initially posted on December 1st, 2014 and recently updated on February 3rd 2022."

Answered by AI

What is the current maximum capacity for participants in this experiment?

"Correct. Clinicaltrials.gov data indicates that this research endeavour, which was first posted on December 1st 2014, is actively soliciting participants to take part in the study. 51 individuals need to be enrolled from a single medical site."

Answered by AI

Could you provide details of other investigations that have been conducted with Cabazitaxel?

"Presently, there are 992 studies related to Cabazitaxel with 338 of them currently in Phase 3. Most trials for this medication take place in the city of Shanghai; however, it is also being tested at 53600 other sites around the world."

Answered by AI
~9 spots leftby Apr 2026