Pemetrexed for Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation
Phase-Based Progress Estimates
Effectiveness
Safety
Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation+8 More
Pemetrexed - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
This trial is testing a combination of drugs to treat urothelial cancer that has spread. Pemetrexed may stop tumor cell growth by blocking enzymes needed for cell growth. Avelumab is an immunotherapy that may help the body's immune system attack the cancer, and may stop tumor cells from growing and spreading.
Eligible Conditions
- Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation
- Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant
- Urinary Bladder
- Metastatic Ureter Urothelial Carcinoma
- MTAP Negative
- Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
Treatment Effectiveness
Effectiveness Progress
Other trials for Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Time from the trial entry to the first documented tumor progression as determined by the investigator using the RECIST v1.1 criteria or death from any cause, whichever occurs first, assessed up to 2 years
Year 2
Progression free survival
Year 2
Overall survival
Up to 2 years
Overall response rate
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Other trials for Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation
Side Effects for
Gemcitabine Plus Cisplatin (GC)
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%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Cough
6%Hyponatraemia
6%Lymphopenia
6%Blood creatinine increased
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Dyspnoea
1%Pulmonary embolism
1%Superior vena cava syndrome
1%Cerebral infarction
1%Embolism venous
1%Ischaemic stroke
Trial Design
1 Treatment Group
Treatment (pemetrexed, avelumab)
1 of 1
Experimental Treatment
18 Total Participants · 1 Treatment Group
Primary Treatment: Pemetrexed · No Placebo Group · Phase 2
Treatment (pemetrexed, avelumab)Experimental Group · 2 Interventions: Avelumab, Pemetrexed · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
Pemetrexed
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from the trial entry to the first documented tumor progression as determined by the investigator using the recist v1.1 criteria or death from any cause, whichever occurs first, assessed up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,870 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,745 Total Patients Enrolled
Amishi Y ShahPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Patients who received methotrexate-containing chemotherapy (e.g.
You have a liver enzyme level of AST or ALT greater than 2.5 x ULN or 5 x ULN if you have documented liver metastases.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments