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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.

Must not have

Patients with an active, or likely to become active second malignancy.

Female subject is pregnant or breast-feeding.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am using or willing to use birth control during the study.

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My cancer is confirmed by biopsy and has no standard treatment.

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My heart's pumping ability is at least 45%, despite past heart issues or specific cancer treatment.

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My kidney function tests are within normal range.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer can be measured or seen on tests.

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My liver functions are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another type of cancer that is active or might become active.

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I am currently pregnant or breastfeeding.

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I have moderate to severe nerve damage in my hands or feet.

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It's been over 6 weeks since my pelvic radiation, and less than 10% of my bone marrow was irradiated.

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I do not have uncontrolled brain metastases or CNS disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Dyspnoea

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1920

Bortezomib

2005

Completed Phase 3

~1410