Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT00072150
• Date of registration: 04/11/2003
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
• Scientific title: Phase II Trial of PS-341 (Bortezomib) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
• Date of first enrolment: October 2003
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00072150
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jonathan Rosenberg
• Affiliation: Cancer and Leukemia Group B

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter

Recurrent Bladder Cancer

Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter

Recurrent Urethral Cancer

Stage III Bladder Cancer

Stage III Urethral Cancer

Stage IV Bladder Cancer

Stage IV Urethral Cancer

Transitional Cell Carcinoma of the Bladder

Ureter Cancer

Intervention(s)

Drug: bortezomib

Primary Outcome(s)

Response rates (CR+PR) determined according to the RECIST criteria [Time Frame: Up to 6 years]

Secondary Outcome(s)

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]

Overall survival [Time Frame: From the date of initiation of treatment to date of death due to any cause, assessed up to 6 years]

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]

Toxicity by type, frequency, and severity [Time Frame: Up to 6 years]

Secondary ID(s)

CALGB-90207

CDR0000335517

NCI-2012-02787

U10CA031946

Source(s) of Monetary Support

Please refer to primary and secondary sponsors