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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rates (CR+PR) determined according to the RECIST criteria

Outcome Description:

95% confidence intervals will be computed using the binomial distribution.

Outcome Time Frame:

Up to 6 years

Safety Issue:

No

Principal Investigator

Jonathan Rosenberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02787

NCT ID:

NCT00072150

Start Date:

October 2003

Completion Date:

Related Keywords:

  • 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
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Kidney Neoplasms

Name

Location

UCSF-Mount ZionSan Francisco, California  94115