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

NCT00072150 | Completed Phase 2

• 3 other identifiers: NCI-2012-02787CALGB-90207U10CA031946
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 6 years

Secondary Outcomes (4)

• Duration of objective response

  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

• Toxicity by type, frequency, and severity

  Up to 6 years

• Progression free survival

  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

• Overall survival

  From the date of initiation of treatment to date of death due to any cause, assessed up to 6 years

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

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.

Drug: bortezomib

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

UCSF-Mount Zion

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms; Ureteral Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jonathan Rosenberg

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: October 1, 2003
• Primary Completion: March 1, 2006
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)