Pemetrexed for Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation+8 More
Pemetrexed - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01005680) in the Gemcitabine Plus Cisplatin (GC) ARM group. Side effects include: Neutropenia with 51%, Leukopenia with 47%, Nausea with 46%, Vomiting with 43%, Anaemia with 35%.

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 preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

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.