← Back to Search

Gemcitabine + Cisplatin for Bladder Cancer

Q: Has the combination of Gemcitabine and Cisplatin been officially sanctioned by the FDA?

Although there is some evidence that Gemcitabine and Cisplatin are safe, as this trial is only in Phase 2, the team at Power have given it a rating of 2 on their safety scale.

Q: What is the maximum enrollment capacity of this medical trial?

This trial is not accepting candidates at the moment. It was initially advertised on December 14th, 2010, and had its most recent update on January 3rd 2022. If you are searching for other trials, there are currently 2515 clinical studies that are actively recruiting patients with carcinoma transitional cell symptoms and 971 research opportunities involving Gemcitabine and Cisplatin available right now.

Q: To what extent has research on Gemcitabine and Cisplatin been explored?

As of this moment, 971 clinical trials are underway to assess the efficacy and safety of Gemcitabine and Cisplatin. 336 of these investigations have advanced to Phase 3, with a large concentration centred in Shanghai but encompassing over 50 000 sites across the globe.

Q: Are there any healthcare facilities in Canada actively conducting this research?

Currently, this clinical trial is recruiting at 9 different medical facilities. These include Memorial Sloan Kettering <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center @ Suffolk in Commack, Hartford Hospital (Data Collection Only) in Hartford, and the flagship site of Memorial Sloan Kettering Cancer Center in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City as well as 6 additional centres.

Q: Does this research study have any open enrollment at present?

Unfortunately, this specific clinical trial has stopped searching for participants. Initially posted on December 14th 2010 and most recently amended January 3rd 2022; however, there are still 2515 trials actively looking to enroll patients with carcinoma or transitional cell as well as 971 studies involving Gemcitabine/Cisplatin that require volunteers.

Q: What are Gemcitabine and Cisplatin commonly employed to combat?

Gemcitabine and Cisplatin are frequently used to manage neoplasm metastasis, as well as <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, testicular carcinoma in situ, and <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/sclc">SCLC</a>).

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

I am mostly able to care for myself.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To define the pathologic response rate (<pT2)

Secondary outcome measures

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

46%

Aspartate aminotransferase increased

38%

Nausea

38%

Alanine aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Fatigue

25%

Constipation

25%

Disease Progression

25%

Disease progression

21%

Hyperkalaemia

21%

Diarrhoea

21%

Asthenia

21%

Decreased appetite

17%

Stomatitis

17%

Cough

17%

Red blood cell count decreased

17%

Pruritus

17%

Platelet count decreased

13%

Dyspnoea

13%

Gamma-glutamyltransferase increased

13%

Blood bilirubin increased

13%

Vomiting

13%

Abdominal pain

13%

Pyrexia

13%

Rash

Oedema peripheral

Abdominal pain upper

Neutrophil count decreased

Hyperbilirubinaemia

Hyponatraemia

Headache

Arthralgia

Hypoalbuminaemia

Insomnia

Bronchitis

Lymphocyte count decreased

Weight decreased

Hypophosphataemia

Abdominal distension

Hypokalaemia

Dehydration

Oesophageal varices haemorrhage

Mouth ulceration

Gastrooesophageal reflux disease

White blood cell count decreased

Muscle spasms

Renal failure

Hypercalcaemia

Hypomagnesaemia

Dysgeusia

Ascites

Acute kidney injury

Blood creatinine increased

Pelvic venous thrombosis

Dysphagia

Hepatic enzyme abnormal

Tumour pain

Dyspepsia

Abdominal infection

Hyperglycaemia

Flank pain

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 4A

Cohort 5A

Cohort 1A

Cohort 1B

Cohort 2A

Cohort 3A

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hartford HospitalOTHER

133 Previous Clinical Trials

18,873 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,563 Total Patients Enrolled

Mayo ClinicOTHER

3,205 Previous Clinical Trials

3,766,727 Total Patients Enrolled

Media Library

Gemcitabine and Cisplatin Clinical Trial Eligibility Overview. Trial Name: NCT01261728 — Phase 2

Bladder Cancer Research Study Groups: Gemcitabine and Cisplatin

Bladder Cancer Clinical Trial 2023: Gemcitabine and Cisplatin Highlights & Side Effects. Trial Name: NCT01261728 — Phase 2

Gemcitabine and Cisplatin 2023 Treatment Timeline for Medical Study. Trial Name: NCT01261728 — Phase 2

Frequently Asked Questions

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

Has the combination of Gemcitabine and Cisplatin been officially sanctioned by the FDA?

"Although there is some evidence that Gemcitabine and Cisplatin are safe, as this trial is only in Phase 2, the team at Power have given it a rating of 2 on their safety scale."

Answered by AI

What is the maximum enrollment capacity of this medical trial?

"This trial is not accepting candidates at the moment. It was initially advertised on December 14th, 2010, and had its most recent update on January 3rd 2022. If you are searching for other trials, there are currently 2515 clinical studies that are actively recruiting patients with carcinoma transitional cell symptoms and 971 research opportunities involving Gemcitabine and Cisplatin available right now."

Answered by AI

To what extent has research on Gemcitabine and Cisplatin been explored?

"As of this moment, 971 clinical trials are underway to assess the efficacy and safety of Gemcitabine and Cisplatin. 336 of these investigations have advanced to Phase 3, with a large concentration centred in Shanghai but encompassing over 50 000 sites across the globe."

Answered by AI

Are there any healthcare facilities in Canada actively conducting this research?

"Currently, this clinical trial is recruiting at 9 different medical facilities. These include Memorial Sloan Kettering Cancer Center @ Suffolk in Commack, Hartford Hospital (Data Collection Only) in Hartford, and the flagship site of Memorial Sloan Kettering Cancer Center in New york City as well as 6 additional centres."

Answered by AI

Does this research study have any open enrollment at present?

"Unfortunately, this specific clinical trial has stopped searching for participants. Initially posted on December 14th 2010 and most recently amended January 3rd 2022; however, there are still 2515 trials actively looking to enroll patients with carcinoma or transitional cell as well as 971 studies involving Gemcitabine/Cisplatin that require volunteers."

Answered by AI

What are Gemcitabine and Cisplatin commonly employed to combat?

"Gemcitabine and Cisplatin are frequently used to manage neoplasm metastasis, as well as bladder cancer, testicular carcinoma in situ, and small cell lung cancer (SCLC)."

Answered by AI

Recent research and studies

Clinical Genitourinary CancerJournal

Neoadjuvant Versus Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: A Microsimulation Model

Hird, Amanda E., Diana E. Magee, Douglas C. Cheung, Beate Sander, Srikala Sridhar, Robert K. Nam, and Girish S. Kulkarni. 2021. “Neoadjuvant Versus Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: A Microsimulation Model”. Clinical Genitourinary Cancer. Elsevier BV. doi:10.1016/j.clgc.2020.10.001.

clinicaltrials.govStudy

Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma

2010. "Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01261728.

All > Mci