A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

NCT00476827 | Terminated Phase 2 Results

• 3 other identifiers: Pro00014926AVF4124s9597-07-4R0
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

Our hypothesis is that this study design, in which bevacizumab is added to one of six single agent chemotherapies with proven activity in metastatic breast cancer, will result in regression or stabilization of this disease in a safe and tolerable manner.

Conditions

Breast Cancer

Keywords

Breast Cancer; Metastatic; Brain; Anti-angiogenesis

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria.

  Primary endpoint has not been analysed secondary to slow and low accrual numbers.

  May 2009

• Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer

  Due to slow accrual study was prematurely closed and endpoint not analysed

  trial closure

Secondary Outcomes (2)

• Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival.

  8 to 9 weeks

• To Assess the Quality of Life During Treatment With This Therapeutic Approach

  8 to 9 weeks

Study Arms (6)

Bevacizumab / Capecitabine

ACTIVE COMPARATOR

Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.

Drug: Bevacizumab

Bevacizumab / Docetaxel

ACTIVE COMPARATOR

Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.

Drug: Docetaxel

Bevacizumab /Irinotecan (Camptosar®, CPT-11)

ACTIVE COMPARATOR

CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.

Drug: CPT-11

Bevacizumab / Paclitaxel

ACTIVE COMPARATOR

Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.

Drug: Paclitaxel

Bevacizumab /Vinorelbine Tartrate

ACTIVE COMPARATOR

Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.

Drug: Vinorelbine Tartrate

Bevacizumab / Gemcitabine

ACTIVE COMPARATOR

Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.

Drug: Gemcitabine

Interventions

Bevacizumab DRUG

Bevacizumab(Avastin) 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. until progression or unacceptable toxicity develops

Also known as: Avastin

Bevacizumab / Capecitabine

Docetaxel DRUG

Docetaxel 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops

Also known as: Taxotere

Bevacizumab / Docetaxel

CPT-11 DRUG

CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops

Also known as: Irinotecan, Camptosar

Bevacizumab /Irinotecan (Camptosar®, CPT-11)

Paclitaxel DRUG

Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops

Also known as: Taxol

Bevacizumab / Paclitaxel

Vinorelbine Tartrate DRUG

Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops

Also known as: Navelbine®

Bevacizumab /Vinorelbine Tartrate

Gemcitabine DRUG

Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.until progression or unacceptable toxicity develops

Also known as: difluorodeoxycytidine

Bevacizumab / Gemcitabine

Eligibility Criteria

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

You may qualify if:

• Female, 18+, with evaluable metastatic breast cancer and stable brain metastases
• Must have received definitive radiotherapy
• No evidence, or history of, central nervous system hemorrhage
• Adequate organ and hematological function

You may not qualify if:

• Active infection, non-healing wound, or history of any bleeding diathesis or coagulopathy
• Uncontrolled hypertension, congestive heart failure, peripheral vascular disease

Sponsors & Collaborators

• Duke University: lead
• Genentech, Inc.: collaborator

Study Sites (4)

Palm Beach Cancer Center Institute

West Palm Beach, Florida, 33401-3406, United States

Location

Presbyterian Health Care

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab; Docetaxel; Irinotecan; Paclitaxel; Vinorelbine; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Kimberly Blackwell, MD
• Organization: Duke University

kimberly.blackwell@duke.edu

919-668-1748

Study Officials

• Kimberly Blackwell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 17, 2013
• Results First Posted: July 17, 2013

Record last verified: 2013-07

Locations

US (4)