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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

Must not have

Documented history of vesicoureteral reflux or an indwelling urinary stent

Inadequate organ and bone marrow function as evidenced by specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks from baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

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My bladder cancer is confirmed and not spread into the muscle.

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My cancer came back after standard bladder treatment.

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My bladder cancer has not responded to BCG treatment or has come back.

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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 am over 18 and can understand and sign the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of bladder reflux or currently have a urinary stent.

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My organ and bone marrow functions are not meeting certain health standards.

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I am not currently on any chemotherapy treatments.

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I have been diagnosed with another cancer within the last 6 months.

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I am not pregnant or breastfeeding.

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I am not taking strong drugs that affect liver enzymes.

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I've had a severe allergic reaction to docetaxel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks from baseline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

70%

Fatigue

48%

Anemia

44%

Nausea

35%

Neutropenia

33%

Abdominal pain

33%

Diarrhea

33%

Vomiting

30%

Constipation

26%

Edema limbs

26%

Peripheral sensory neuropathy

26%

decreased WBC count

22%

Abdominal distension

22%

Dyspnea

19%

Anxiety

19%

Insomnia

15%

Hypotension

15%

Cough

15%

Dizziness

13%

Decreased white blood cell count

11%

Urinary frequency

11%

Dyspepsia

11%

decreseaed neutrophill count

11%

Weight loss

11%

Dysuria

Death

Thromboembolic event

Dysphagia

Flatulence

Increased Abdominal Girth

Paresthesia

Depression

Hematuria

Dry skin

Hypertension

Alopecia

generalized weakness

Gastric hemorrhage

Lightheadedness

Weakness

Fever

Early Satiety

renal failure

Positive blood culture

decreased urine output

balance difficulty

Pleural Effusion

Abdominal Pain

Acute Kidney Failure

Mycoplasma pneumoniae

Acinetobacter baumanii bacteremia

Ascites

Bacteremia

Increased generalized weakness

Dehydration

Nasal congestion

Shortness of Breath

Nephrolithiasis (Kidney Stone)

Difficulty Urinating

Allergic reaction

Decreased Appetite

Mouth ulcer

Loose Stools

Right Upper Quadrant Pain

hyperlipidemia

Gastric Hemorrhage

Hypocalcemia

Myelosuppression

Cardiac arrest

Gastrointestinal pain

Mucositis oral

Stomach pain

Anasarca

Anal fissure

burping

Skin Changes

Hypokalemia

Dysguesia

Poor Appetite

Hypoalbuminemia

Poor Oral Intake

Headache

hypersensitivity

Agitation

Cystitis noninfective

Nocturia

UROSEPSIS

Prostatitis

Bengin enlargement of Prostate

Hydrouretroneprosis

benign prostatic hypertrophy

urosepsis

Hydronephrosis

Renal Failure

Urinary tract obstruction

Hiccups

Allergic rhinitis

Epistaxis

VATS pleurodesis

Sore throat

Hypohidrosis

Nail discoloration

slow skin turgor

Rash

flushing

Nodular findings

easy bruisability

Hyperhidrosis

Rectal Obstruction

mouth sore

Sepsis

Bacteruria

Bone Mets

Dysgeusia

Hypothyroidism

Chills

Dysmenorrhea

Concentration impairment

Bloating

Edema- Scrotal

Rash on Neck

Weight Change

Body aches

Proteinuria

Hyponatremia

Clostridium difficle

intermittent low appetite

neuropathy to fingers

hiatal hernia

Elevated CEA

cold intolerance

Urinary Tract Infection

Urinary Tract Obstruction

increased tears

early satiety

Localized edema

Malaise

Non-cardiac chest pain

Rigors

Big white light and dizziness

decreased absolute lymphocyte count

decreased platelets

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Prior Taxane Therapy)

Arm A (Taxane naïve)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1920

Cisplatin

2013