Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer

NCT00017394 | Completed Phase 2

• 3 other identifiers: NCI-2012-0238801-013CDR0000068685
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells

Conditions

Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate to combination therapy with bevacizumab and vinorelbine, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  Up to 6 years

Secondary Outcomes (2)

• Time to progression

  Time from the first treatment on study until the time of documented disease progression, assessed up to 6 years

• Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

  Up to 6 years

Study Arms (1)

Treatment (bevacizumab, vinorelbine tartrate)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.

Biological: bevacizumab; Drug: vinorelbine tartrate; Other: laboratory biomarker analysis

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (bevacizumab, vinorelbine tartrate)

vinorelbine tartrate DRUG

Given IV

Also known as: Eunades, navelbine ditartrate, NVB, VNB

Treatment (bevacizumab, vinorelbine tartrate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (bevacizumab, vinorelbine tartrate)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed stage IV breast cancer
• Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
• Must meet 1 of the following criteria:
• Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
• Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
• At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
• At least 20 mm by conventional techniques
• At least 10 mm by spiral CT scan
• No CNS metastases by CT scan or MRI within the past 6 weeks
• No prior or concurrent primary CNS tumor on physical exam
• Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
• HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
• Hormone receptor status:
• Not specified
• Male or female

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

Bevacizumab; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Harold Burstein

  Dana-Farber Cancer Institute

  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: June 6, 2001
• First Posted: June 12, 2003
• Study Start: March 1, 2001
• Primary Completion: September 1, 2007
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)