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Anti-tumor antibiotic

Gemcitabine + Docetaxel for Bladder Cancer (GEMDOCE Trial)

Phase 2

Waitlist Available

Led By Max Kates, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0, 1, or 2

Be older than 18 years old

Must not have

Subjects with another active second malignancy with an estimated overall survival from the second malignancy of < 12 months

Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for bladder cancer that has not yet been proven safe or effective. If the new therapy is found to be both safe and effective, it could become the new standard of care.

Who is the study for?

This trial is for adults with early-stage bladder cancer that hasn't spread into the muscle. They should be in fairly good health, not pregnant or breastfeeding, and haven't had certain cancer treatments recently. People with more advanced cancer, another serious active cancer, or those who've used gemcitabine or docetaxel for other cancers can't join.

What is being tested?

The study tests a combination of two drugs, Gemcitabine and Docetaxel, given directly into the bladder to treat patients who have never received BCG therapy. It's an open-label phase 2 study which means everyone gets the treatment and researchers track its safety and effectiveness.

What are the potential side effects?

Potential side effects may include irritation inside the bladder, urinary symptoms like increased frequency or discomfort when urinating, allergic reactions to medications used, as well as possible blood disorders.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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I have another cancer with a life expectancy of less than 12 months.

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I received cancer treatment less than 4 weeks ago or am still experiencing side effects.

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My bladder cancer is advanced and cannot be surgically removed.

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I have cancer in my upper urinary tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

3-Month Complete Response Rate

Secondary study objectives

12-Month Relapse-Free Survival Rate

24-Month Relapse-Free Survival Rate

Safety Profile as Assessed by Proportion of Adverse Events by Grade

+1 more

Other study objectives

Number of DNA Mutations as Measured by Panel DNA Sequencing

Number of DNA Mutations as Measured by Whole Exome

Number of DNA Mutations as Measured by Whole Transcriptome

+7 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Intravesical Gemcitabine/DocetaxelExperimental Treatment2 Interventions

Gemcitabine/Docetaxel induction is given intravesically in sequential order once a week for six consecutive weeks. One gram of gemcitabine in 50 ml of sterile water is slowly instilled into the bladder via a Foley catheter and the catheter is clamped for 60 minutes. The bladder is then drained and 40 mg of docetaxel in 50 ml of NSS is then slowly instilled via the Foley catheter into the bladder. The catheter is again clamped for 60 minutes before draining. If initial efficacy seen, patients will have monthly maintenance instillations of Gemcitabine/Docetaxel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

FDA approved

Gemcitabine

FDA approved

0 / 5Eligibility criteria met