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

Part of paid clinical trials in West Palm Beach, Florida.

Sponsor
Duke University
Study ID
NCT00476827
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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
  • 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
  • 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
  • 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
  • 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

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Jul 2013
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab / Capecitabine
    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.
  • Active Comparator: Bevacizumab / Docetaxel
    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.
  • Active Comparator: Bevacizumab /Irinotecan (Camptosar®, CPT-11)
    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.
  • Active Comparator: Bevacizumab / Paclitaxel
    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.
  • Active Comparator: Bevacizumab /Vinorelbine Tartrate
    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.
  • Active Comparator: Bevacizumab / Gemcitabine
    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.

Primary Outcome Measure

Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria. [ Time Frame: May 2009 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Palm Beach Cancer Center InstituteWest Palm BeachFlorida33401-3406-
Presbyterian Health CareCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Virginia Oncology AssociatesNewport NewsVirginia23606-

Find similar trials in West Palm Beach, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Palm Beach Cancer Center Institute· West Palm Beach, FLPresbyterian Health Care· Charlotte, NCDuke University Medical Center· Durham, NCVirginia Oncology Associates· Newport News, VA

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