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Anti-metabolites

Gemcitabine Hydrochloride for Renal Pelvis and Ureter Cancer

Phase 2
Waitlist Available
Led By Stephen A Boorjian
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine < 2.2 mg/dL (194 mmol/L)
Hemoglobin > 9 g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying gemcitabine to see if it can prevent urothelial cancer from recurring in the bladder for patients with upper urinary tract urothelial cancer.

Eligible Conditions
  • Renal Pelvis and Ureter Cancer
  • Ureter Cancer
  • Renal Pelvis Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urothelial Carcinoma Relapse-free Survival
Secondary outcome measures
Incidence of Adverse Events
Time to Recurrence
Other outcome measures
Incidence of Muscle-invasive Bladder Cancer
Time to Death
Time to Development of Muscle-invasive Bladder Cancer

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986
97%
Neutropenia
94%
Leukopenia
80%
Anemia
76%
Thrombocytopenia
47%
Gastrointestinal
43%
Constitutional
38%
Other Hemotologic
34%
Pain
17%
Infection/Fever
17%
Peripheral neurologic
17%
Pulmonary
14%
Neurologic
11%
Metabolic
10%
2nd Primary
9%
Hepatic
8%
Dermatologic
7%
Cardiovascular
6%
Allergy
6%
Hemorrhage
5%
Genitourinary/Renal
5%
Musculoskeletal
4%
Ocular/Visual
3%
Endocrine
2%
Auditory
2%
Thrombosis/Embolism
1%
Ileus
1%
Infection Documented W Grd 3/4 Neutropn.
1%
Infection Without Neutropenia
1%
Coagulation
1%
Sexual
1%
Platelets
1%
Allergic Reaction/Hypersensitivity
1%
Febrile Neutropenia-Fuo Infect Not Docum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carbo/Gemcitabine - Carbo/Taxol
Carbo/Taxol/Gemcitabine
Carbo/Taxol/Doxil
Carbo/Topotecan - Carbo/Taxol
Carbo/Taxol

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (gemcitabine hydrochloride)Experimental Treatment1 Intervention
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,759 Total Patients Enrolled
Stephen A BoorjianPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
34 Total Patients Enrolled

Frequently Asked Questions

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

Will patients experience any dangerous side-effects from Gemcitabine Hydrochloride?

"While Phase 2 trials are not as reliable in terms of evidence, our team believes that Gemcitabine Hydrochloride is safe enough to be given a score of 2."

Answered by AI

Are there precedent studies which have utilized Gemcitabine Hydrochloride?

"464 studies are currently investigating gemcitabine hydrochloride. Of these ongoing research projects, 137 have reached phase 3. The majority of these trials for gemcitabine hydrochloride are based in Adelaide, South Australia; however, 24669 other locations worldwide are also running similar investigations."

Answered by AI

How many people are currently signed up to participate in this trial?

"This specific study is not recruiting any more patients. However, if you are looking for other trials, there are presently 178 trials actively admitting patients with malignant neoplasm of ureter and 464 studies for Gemcitabine Hydrochloride that still need participants."

Answered by AI

Is Gemcitabine Hydrochloride used to help patients with cancer?

"small cell lung cancer (sclc) is most often treated with Gemcitabine Hydrochloride. However, this medication can also target head and neck carcinoma, pancreatic adenocarcinoma locally advanced, and cervical cancers."

Answered by AI

Are there many hospitals participating in this trial throughout the state?

"The research is being conducted at University of Pittsburgh Cancer Institute (UPCI), Wake Forest Baptist Medical Center, Mayo Clinic in Rochester and 7 other locations."

Answered by AI

Are there any vacancies in this study for new test subjects?

"As of July 5th, 2022, this clinical trial is no longer recruiting patients. The posting for the trial was first made on June 5th, 2020. If you are looking for other trials, there are presently 178 clinical trials actively recruiting participants with malignant neoplasm of ureter and 464 trials for Gemcitabine Hydrochloride enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Stephen A. Boorjian, M.D. 2020. "Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04398368.
~5 spots leftby Apr 2025
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