- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072150
Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Phase II Trial of PS-341 (Bortezomib) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Study Overview
Status
Conditions
- Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
- Recurrent Bladder Cancer
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
- Stage III Bladder Cancer
- Stage IV Bladder Cancer
- Transitional Cell Carcinoma of the Bladder
- Ureter Cancer
- Recurrent Urethral Cancer
- Stage III Urethral Cancer
- Stage IV Urethral Cancer
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the efficacy of PS-341 in patients with measurable advanced urothelial transitional cell carcinoma who have not responded to, or have relapsed after one prior conventional chemotherapy.
II. To determine the safety and toxicity of PS-341 administered in this group of patients.
III. To estimate duration of objective response, progression-free survival and overall survival in this group of patients.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients with a solitary site of disease (i.e., lung or nodal metastases) and who have a partial response (PR) may be considered for surgical resection. Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy. Patients who achieve a complete response, either through resection or bortezomib therapy, receive 2 additional courses of study therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 13-17 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94115
- UCSF-Mount Zion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologic diagnosis of transitional cell carcinoma (TCC) of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
- All patients must have received only one prior systemic chemotherapy regimen for advanced or metastatic disease (which must have included at least one of the following chemotherapy agents: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine), with progression documented during or after that treatment; neoadjuvant as well as adjuvant combination chemotherapy is considered a systemic chemotherapy; radiosensitizing single agent chemotherapy is not considered prior systemic therapy
- Patients must have completed radiotherapy (RT) or chemotherapy >= 4 weeks prior to registration on this trial; patients must have recovered from previous treatments or returned to their baseline in the judgment of the enrolling physician
- No Prior treatment with PS-341 or other proteasome inhibitors
- No prior treatment with investigational agents as single agent therapy; however, the incorporation of an investigational agent into the prior systemic chemotherapy regimen is allowed
Patients must have measurable disease;
- Measurable Disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as >10 mm with spiral CT scan
Non-measurable disease: Patients with ONLY non-measurable disease are not eligible for this trial
Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include the following:
- Bone lesions;
- Leptomeningeal disease;
- Ascites;
- Pleural/pericardial effusion;
- Inflammatory breast disease;
- Lymphangitis cutis/pulmonis;
- Abdominal masses that are not confirmed and followed by imaging techniques;
- Cystic lesions
- Primary bladder masses
- CTC (ECOG) performance status =< 2
- Patients must have =< grade 1 peripheral neuropathy at baseline
- No known active brain metastases; patients may not have evidence of active brain metastases; screening CT or MRI is not required, unless there is clinical suspicion of brain metastases
- Pregnant and/or nursing women are not eligible for this trial as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study; pregnant and/or nursing women are not eligible for this trial as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
- Creatinine =< 2.5 mg/dl or measured or calculated creatinine clearance > 30 ml/min)
- ALT and AST =< 2.5 x ULN
- Total bilirubin =< 1.8 mg/dL
- Granulocytes >= 1500/mm^3
- Platelets >= 100,000/mm^3
- Hemoglobin >= 8 g/dl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (bortezomib)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with a solitary site of disease (i.e., lung or nodal metastases) and who have a partial response (PR) may be considered for surgical resection. Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy. Patients who achieve a complete response, either through resection or bortezomib therapy, receive 2 additional courses of study therapy. |
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rates (CR+PR) determined according to the RECIST criteria
Time Frame: Up to 6 years
|
95% confidence intervals will be computed using the binomial distribution.
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Up to 6 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of objective response
Time Frame: From the date of the first CR or PR to the date that the patient had disease progression (or death), assessed up to 6 years
|
The Kaplan-Meier product-limit method will be used to estimate.
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From the date of the first CR or PR to the date that the patient had disease progression (or death), assessed up to 6 years
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Toxicity by type, frequency, and severity
Time Frame: Up to 6 years
|
95% confidence intervals for the toxicity rates will be computed using the binomial distribution.
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Up to 6 years
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Progression free survival
Time Frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 6 years
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The Kaplan-Meier product-limit method will be used to estimate.
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From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 6 years
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Overall survival
Time Frame: From the date of initiation of treatment to date of death due to any cause, assessed up to 6 years
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The Kaplan-Meier product-limit method will be used to estimate.
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From the date of initiation of treatment to date of death due to any cause, assessed up to 6 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Rosenberg, Cancer and Leukemia Group B
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Disease Attributes
- Ureteral Diseases
- Urethral Diseases
- Kidney Neoplasms
- Carcinoma
- Recurrence
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Urethral Neoplasms
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- NCI-2012-02787
- U10CA031946 (U.S. NIH Grant/Contract)
- CALGB-90207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
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University of British ColumbiaRecruitingTransitional Cell Cancer of the Renal Pelvis and Ureter | Urothelial Carcinoma of the Renal Pelvis and UreterCanada
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National Cancer Institute (NCI)TerminatedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | Transitional Cell Carcinoma of the Bladder | Localized Transitional Cell Cancer of the...United States
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UroGen Pharma Ltd.WithdrawnCarcinoma | Transitional Cell Carcinoma | Transitional Cell Cancer of the Renal Pelvis and UreterIsrael, United States
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National Cancer Institute (NCI)CompletedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Bladder Cancer | Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional...Canada
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National Cancer Institute (NCI)CompletedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Transitional Cell Cancer of the Renal Pelvis and UreterUnited States
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Steba Biotech S.A.PrimeVigilance; ICON plcRecruitingTransitional Cell Cancer of Renal Pelvis and UreterUnited States, Israel, Spain, Italy, France, Germany, Austria
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Bladder Cancer | Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Bladder Cancer | Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Squamous Cell Carcinoma of the BladderUnited States
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National Cancer Institute (NCI)CompletedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Bladder Cancer | Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional... and other conditionsUnited States
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National Cancer Institute (NCI)TerminatedMetastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | Recurrent Bladder Cancer | Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional... and other conditionsUnited States
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