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Gemcitabine + Cisplatin for Bladder Cancer

Phase 2

Waitlist Available

Led By Jonathan Coleman, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Required Initial Laboratory Values: Absolute neutrophil count ≥ 1500 cells/mm3, Platelets ≥ 100,000 cells/mm3, Hemoglobin ≥ 9.0g/dL, Bilirubin ≤ 1.2, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution, Alkaline phosphatase ≤ 2.5 x ULN for the institution, Serum creatinine ≤ 1.3 mg/dL if male or ≤ 1.1 mg/dL if female OR calculated creatinine clearance ≥ 55 ml/min/1.73m^2, If female of childbearing potential, serum pregnancy test is negative, Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.

Age ≥ 18 years of age

Must not have

Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2

Serious intercurrent medical or psychiatric illness, including serious active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if getting chemotherapy can help shrink a tumor before surgery for kidney cancer.

Who is the study for?

This trial is for adults with high-grade upper tract transitional cell carcinoma who are fit for kidney surgery. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use effective contraception, and have no recent major heart issues or surgeries. Prior systemic chemotherapy disqualifies them.

What is being tested?

The study tests if Gemcitabine and Cisplatin chemotherapy given over four cycles (each lasting 21 days) can shrink kidney tumors before surgery. The treatment spans a total of 12 weeks.

What are the potential side effects?

Potential side effects include nausea, vomiting, low blood counts leading to increased infection risk or bleeding problems, kidney damage, nerve damage causing numbness or tingling in hands and feet, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is a high-grade type in the upper urinary tract, confirmed by tests.

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I am a suitable candidate for major kidney or ureter surgery, as determined by a specialist.

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I am mostly able to care for myself.

Exclusion Criteria

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

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I have a heart rhythm problem that is moderate to severe.

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I do not have any serious ongoing health or mental health conditions.

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I have had radiation therapy to my bladder.

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I have severe numbness or pain in my hands or feet.

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I have severe heart disease that limits my daily activities.

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My cancer is in the earliest stage, not spread beyond the original site.

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My blood pressure is high (>150/100 mmHg) even with medication.

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I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To define the pathologic response rate (<pT2)

Secondary study objectives

To determine overall survival of patients

Disease

To evaluate the safety and tolerability

Side effects data

From 2022 Phase 1 & 2 trial • 93 Patients • NCT03684811

54%

Nausea

50%

Fatigue

31%

Diarrhoea

31%

Alanine aminotransferase increased

31%

Headache

27%

Constipation

27%

Fall

23%

Disease Progression

23%

Disease progression

19%

Aspartate aminotransferase increased

19%

Vomiting

19%

Dysgeusia

19%

Seizure

15%

Upper respiratory tract infection

15%

Platelet count decreased

15%

Dizziness

15%

Insomnia

15%

Hypertension

12%

Dyspepsia

12%

Decreased appetite

12%

Hypophosphataemia

12%

Muscular weakness

12%

Paraesthesia

12%

Aphasia

12%

Hemiparesis

12%

Confusional state

12%

Epistaxis

Blood alkaline phosphatase increased

Hot flush

Agitation

Oropharyngeal pain

Vision blurred

Abdominal pain

Dysphagia

Toothache

Weight decreased

Hypokalaemia

Hyperglycaemia

Pain in extremity

Cognitive disorder

Hypoaesthesia

Urinary incontinence

Cough

Dermatitis acneiform

Candida infection

Red blood cell count decreased

Hepatitis acute

Haemorrhage intracranial

Syncope

Pneumothorax

Embolism

Stomatitis

Non-cardiac chest pain

Blood bilirubin increased

Lymphocyte count decreased

Neutrophil count decreased

Blood creatinine increased

Flank pain

Muscle spasms

Back pain

Musculoskeletal pain

Dyspnoea

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1A

Cohort 5A

Cohort 1B

Cohort 2A

Cohort 3A

Cohort 4A

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine and CisplatinExperimental Treatment1 Intervention

This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine and Cisplatin

2018

Completed Phase 2

~100

0 / 13Eligibility criteria met