← Back to Search

Proteasome Inhibitor

Bortezomib + Gemcitabine/Doxorubicin for Urothelial Cancer

Phase 1
Waitlist Available
Led By Arlene Siefker-Radtke, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
All patients must have biopsy proven cancer (i.e. solid tumor) for which there is no standard therapy available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Study Summary

This trial is testing the combination of three drugs to see what the highest tolerable dose is that can be given to patients with urothelial cancer or other solid tumors.

Who is the study for?
This trial is for adults with urothelial cancer or other solid tumors without standard treatment options. Participants must have had prior therapy, be able to perform daily activities (Zubrod status ≤2), and not be pregnant or breastfeeding. They should have normal organ function and agree to use birth control. Those with severe heart disease, active second cancers, significant neuropathy, or allergies to the drugs are excluded.Check my eligibility
What is being tested?
Researchers are testing the highest dose of Gemzar (gemcitabine) and Adriamycin (doxorubicin) that can safely be given with Velcade (bortezomib). The study aims to determine tolerable levels for patients who've exhausted standard treatments for their advanced cancers.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, hair loss from doxorubicin; low blood counts, nerve damage from bortezomib; and flu-like symptoms from gemcitabine. Organ-specific toxicity might also occur due to drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using or willing to use birth control during the study.
Select...
My cancer is confirmed by biopsy and has no standard treatment.
Select...
My heart's pumping ability is at least 45%, despite past heart issues or specific cancer treatment.
Select...
My kidney function tests are within normal range.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer can be measured or seen on tests.
Select...
My cancer is a type that started in the bladder or urinary system and cannot be removed by surgery.
Select...
I have undergone at least one treatment for my condition before.
Select...
My liver functions are within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of Gemzar + Adriamycin Given with Velcade
Secondary outcome measures
Response of Gemzar + Adriamycin Given with Velcade

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
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%
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

1Treatment groups
Experimental Treatment
Group I: Bortezomib + Gemcitabine + DoxorubicinExperimental Treatment3 Interventions
Starting dose of Bortezomib 0.8 mg/m^2 IV Over 3-5 Seconds. Starting dose of Gemcitabine 225 mg/m^2 IV Up to 90 Minutes. Starting dose of Doxorubicin 12.5 mg/m^2 IV Over 15-30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Bortezomib
2005
Completed Phase 2
~1140
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,369 Total Patients Enrolled
3 Trials studying Urethral Cancer
144 Patients Enrolled for Urethral Cancer
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,869 Total Patients Enrolled
Arlene Siefker-Radtke, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Urethral Cancer
46 Patients Enrolled for Urethral Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Sep 2024