Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00072150

Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with advanced transitional cell carcinoma of the urothelium.

Condition	Intervention	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Drug: bortezomib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Bortezomib

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: After 1 treatment to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Time Frame: After 1 treatment until progression or relapse ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: After 1 treatment until death ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	October 2003
Study Completion Date:	April 2009
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bortezomib Treatment of advanced urothelial tract transitional cell carcinoma with bortezomib	Drug: bortezomib 1.3 mg/sq m IV infusion twice weekly for 2 weeks, then one week rest per cycle Other Name: PS-341

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of bortezomib, in terms of the response rate, in patients with previously treated advanced transitional cell carcinoma of the urothelium.

Secondary

Determine the duration of objective response in patients treated with this drug.
Determine the progression-free and overall survival of patients treated with this drug.
Determine the safety and toxicity of this drug in these 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
Previously treated with 1 prior systemic chemotherapy* for advanced or metastatic disease
- Progressive disease during or after chemotherapy regimen
- Must have included at least 1 of the following agents:
  - Cisplatin
  - Carboplatin
  - Paclitaxel
  - Gemcitabine
  - Docetaxel NOTE: *Neoadjuvant and adjuvant combination chemotherapy is considered a systemic chemotherapy, while radiosensitizing single-agent chemotherapy is not
Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Nonmeasurable disease includes 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
No known active brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 8 g/dL

Hepatic

Bilirubin less than 1.8 g/dL
AST and ALT no greater than 2.5 times upper limit of normal

Renal

Creatinine no greater than 2.5 mg/dL OR
Creatinine clearance greater than 30 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study treatment
Standard chemistry panel normal
No peripheral neuropathy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

No concurrent hormonal therapy except for the following:
- Steroids for adrenal failure
- Hormones for non-disease-related conditions (e.g., insulin for diabetes)
- Intermittent dexamethasone as an antiemetic

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered
No concurrent palliative radiotherapy

Surgery

Not specified

Other

No prior bortezomib or other proteasome inhibitors
No prior investigational agents as a single-agent therapy
- Prior investigational agents incorporated into prior systemic chemotherapy allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072150

Show 76 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Jonathan Rosenberg, MD

University of California, San Francisco

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rosenberg JE, Halabi S, Sanford BL, Himelstein AL, Atkins JN, Hohl RJ, Millard F, Bajorin DF, Small EJ; for the Cancer and Leukemia Group B. Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207. Ann Oncol. 2008 Feb 13; [Epub ahead of print]

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00072150 History of Changes
Other Study ID Numbers:	CDR0000335517, U10CA031946, CALGB-90207
Study First Received:	November 4, 2003
Last Updated:	April 6, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

recurrent bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
recurrent transitional cell cancer of the renal pelvis and ureter
stage IV bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter

urethral cancer associated with invasive bladder cancer
stage III bladder cancer
regional transitional cell cancer of the renal pelvis and ureter
anterior urethral cancer
posterior urethral cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012