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Anti-tumor antibiotic, Anti-metabolites
Durvalumab + Chemotherapy for Urothelial Carcinoma
Phase 2 & 3
Recruiting
Led By Jean H Hoffman-Censits
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following: Upper urinary tract mass on cross-sectional imaging or Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology
NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether adding durvalumab to chemotherapy will be more effective than chemotherapy alone in treating patients with upper urinary tract cancer before surgery.
Who is the study for?
Adults with high-grade upper urinary tract cancer who are fit for chemotherapy and surgery. They must have a life expectancy of at least 12 weeks, adequate organ function, no severe hearing loss or neuropathy, not be pregnant or breastfeeding, and willing to use contraception. Excluded if they have small cell/neuroendocrine carcinoma components in their cancer, other active cancers (with some exceptions), uncontrolled illnesses, recent major surgeries, certain autoimmune diseases or treatments.Check my eligibility
What is being tested?
The trial is testing the addition of Durvalumab (an immunotherapy drug) to standard chemotherapy before surgery compared to chemotherapy alone. The goal is to see if combining Durvalumab with chemo can better shrink tumors before they're surgically removed.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs including lungs and intestines; infusion reactions; fatigue; potential harm to an unborn baby hence the need for contraception. Chemotherapy can cause hair loss, nausea/vomiting, increased risk of infection due to low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a severe type of urinary tract cancer within the last 12 weeks.
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I understand a biopsy is necessary for my participation in the study.
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I can take care of myself and am up and about more than half of my waking hours.
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I had hepatitis C but am now treated with no detectable virus, or I am currently being treated with no detectable virus.
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I am 18 years old or older.
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I weigh more than 30 kilograms.
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My hepatitis B virus is undetectable with treatment.
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I have a tumor in my upper urinary tract seen on imaging or during an endoscopy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)
Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)
Secondary outcome measures
Cancer-specific survival (All Patients)
EFS (cisplatin-ineligible cohort: Arm C)
Incidence of adverse events (All Patients)
+4 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
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
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (durvalumab, gemcitabine hydrochloride)Experimental Treatment7 Interventions
Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
Group II: Arm A (durvalumab, chemotherapy)Experimental Treatment11 Interventions
Patients receive durvalumab IV over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
Group III: Arm B (chemotherapy)Active Control10 Interventions
Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and CT or MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Pegfilgrastim
2013
Completed Phase 3
~4410
Vinblastine Sulfate
2007
Completed Phase 4
~300
Computed Tomography
2017
Completed Phase 2
~2720
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Methotrexate
2013
Completed Phase 4
~3800
Durvalumab
2017
Completed Phase 2
~3870
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,656 Total Patients Enrolled
Jean H Hoffman-CensitsPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a severe type of urinary tract cancer within the last 12 weeks.I have never been treated with anthracycline drugs.I've been cancer-free for over 2 years after treatment and haven't had immune therapy.I have not had any major surgery in the last 28 days.I take steroids before certain tests to prevent allergic reactions.Your blood platelet count must be at least 100,000 per microliter, and this should be checked no more than 14 days before participating in the study.I have a history of bladder cancer.I haven't taken immunosuppressive drugs in the last 14 days, except for allowed types like nasal or inhaled steroids.I do not have any serious health issues that are not under control.I understand a biopsy is necessary for my participation in the study.Your bilirubin levels must not be too high (a blood test will be done to check this). If you have Gilbert's disease, your bilirubin levels must be even lower.Your liver function tests done within 14 days before enrolling in the study should show that the levels of AST and ALT are not more than 2.5 times the upper limit of normal for the lab where they were tested.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am eligible for cisplatin, with good kidney function, physical ability, and no severe hearing loss or neuropathy.I am taking no more than 10 mg/day of prednisone or its equivalent.I can take care of myself and am up and about more than half of my waking hours.I haven't needed immunosuppressive therapy for autoimmune diseases in the last 2 years and don't have IBD, Crohn's, or similar conditions.My scans show no signs of cancer spread or large lymph nodes.My cancer is mostly urothelial and does not have small cell/neuroendocrine parts.I have kidney issues, severe hearing loss, significant nerve damage, or I'm mostly in bed.I have a history of cancer that is not related to the bladder.I have no other active cancers except for certain treated or monitored types.You are expected to live for at least 12 more weeks.I have not had radiation on more than 25% of my bone marrow.Your white blood cell count must be at least 3,000 cells per microliter as measured within the past 14 days.I had hepatitis C but am now treated with no detectable virus, or I am currently being treated with no detectable virus.I have not had any live vaccines in the last 30 days and won't during or for 30 days after durvalumab treatment.My white blood cell count is high enough for treatment.My kidney function, measured by creatinine clearance, is adequate.I am 18 years old or older.I weigh more than 30 kilograms.My hepatitis B virus is undetectable with treatment.I had bladder cancer that was treatable with surgery.My heart function is classified as class 2B or better according to the NYHA.Your hemoglobin level, which is a measure of your blood health, needs to be at least 9 grams per deciliter.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My cancer has not spread extensively to other parts of my body.I have a tumor in my upper urinary tract seen on imaging or during an endoscopy.This is the first step of the study where you will be selected randomly to either participate in the study or not.You cannot have had an organ transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (durvalumab, gemcitabine hydrochloride)
- Group 2: Arm A (durvalumab, chemotherapy)
- Group 3: Arm B (chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Where are the sites of this trial taking place?
"There are presently 100 sites enrolling patients for this trial, with locations in and around Milwaukee, Park Ridge, and Rice Lake. To limit travel requirements, please select the location nearest you."
Answered by AI
Has the FDA greenlit Cisplatin for public use?
"Cisplatin received a safety rating of 3 because there is existing clinical data supporting its efficacy and multiple rounds of data affirming its safety."
Answered by AI
How many people are eligible for participation in this research project?
"In order to have a statistically relevant sample size, this study requires 249 patients that meet the necessary qualifications. These individuals can come from different hospitals, such as Aurora Saint Luke's Medical Center in Milwaukee, Wisconsin and Advocate Lutheran General Hospital in Park Ridge, Michigan."
Answered by AI
What types of cancer does Cisplatin help to fight?
"Cisplatin is an effective treatment for patients with small cell lung cancer (sclc), advanced testicular cancer, and bladder cancer."
Answered by AI
What is the precedence for Cisplatin research?
"Cisplatin was first investigated in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, a total of 3317 clinical trials have been completed. As of now, there are 1932 active clinical trials, a sizable number of which are taking place in Milwaukee, Wisconsin."
Answered by AI
Are there any patients that can still join this clinical trial?
"Absolutely. The listing on clinicaltrials.gov makes it clear that this study is actively looking for participants. This trial was first posted on May 6th, 2021 and updated November 4th, 2022. They are hoping to enroll 249 patients at 100 different sites."
Answered by AI
Does this experiment differ from others in a significant way?
"Alfacell Corporation first sponsored a Cisplatin clinical trial back in 1997. Since the original study, which recruited 300 participants, there have been over 1900 additional trials in almost 4000 cities and nearly 100 nations."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
IHA Hematology Oncology Consultants-Brighton
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
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