Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well bortezomib works in treating patients with advanced transitional cell carcinoma of the urothelium.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Bortezomib
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