Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

NCT00574236 | Terminated Phase 2 Results DMC

• 4 other identifiers: 2004-0130CO04101A534260SMPH/MEDICINE
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

  Every two cycles/42 days, up to 7 months

Secondary Outcomes (1)

• Time to Progression

  Up to one year

Study Arms (1)

A

EXPERIMENTAL

Drug: PS-341, doxorubicin

Interventions

PS-341, doxorubicin DRUG

bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle

Also known as: Velcade, Adriamycin

A

Eligibility Criteria

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

You may qualify if:

• Cytologically or histologically confirmed metastatic breast cancer
• Measurable or evaluable disease
• Age \> 18, PS 0,1,2
• MUGA \> 45%
• Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx.
• Must meet designated laboratory criteria within 14 days of enrollment

You may not qualify if:

• Doxorubicin for metatstatic disease.
• Pregnant or lactating.
• Active infections, no myocardial infarction within 2 months of enrollment.
• Investigational drugs within 14 days of enrollment.
• Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
• Neuropathy that is \> grade 2.
• Active brain mets.
• Hypersensitivity to bortezomib, boron, or mannitol.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bortezomib; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Anne Traynor
• Organization: University of Wisconsin Carbone Cancer Center

amt@medicine.wisc.edu

608-262-5092

Study Officials

• James A Stewart, M.D.

  University of Wisconsin PPC Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: August 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 13, 2019
• Results First Posted: April 20, 2018

Record last verified: 2018-04

Locations

US (1)