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A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer

The purpose of this study is to determine whether a new chemotherapy schedule using biweekly
combination of paclitaxel (Taxol®), gemcitabine (Gemzar®) and Avastin would help to lessen
in-between-cycle growth of resistant cells and to evaluate the toxicity of this therapy.

Taxol is approved by the Food and Drug Administration (FDA) for use in metastatic breast and
metastatic ovarian cancer but its use in this study is investigational. Gemzar is FDA
approved for the use in breast, lung and pancreatic cancer but its use in this study is

The Avastin being given in this study is commercially available, however, it has not been
approved by FDA for use in metastatic breast cancer.

Inclusion Criteria:

- Patient must be 18 years of age or older with histologically confirmed breast
cancer and clinical evidence of metastatic disease.

- Patients must have measurable or non-measurable disease. X-rays, scans or physical
examinations used to assess measurable disease must be performed within 28 days prior
to registration. X-rays, scans or physical examinations to assess non-measurable
disease must be completed within 42 days prior to registration. Patients with
effusions or ascites as the only sites of disease are ineligible.

- Patients must meet the following requirements regarding prior and concurrent
chemotherapy:Patients must not have received prior chemotherapy regimens for
metastatic breast cancer. Patients may have received adjuvant/neoadjuvant
chemotherapy, for a total of 3 prior regimens.

- Prior therapy with paclitaxel or docetaxel is allowed in the adjuvant or neoadjuvant
setting, if given > 6 months prior to registration.

- Patients must have >14 days delay between the conclusion of any radiation and the
start of gemcitabine, provided the acute effects of radiation treatment have

- Patients may have received any number of exogenous hormonal therapies and/or
trastuzumab in the adjuvant, neoadjuvant or metastatic setting. Last dose of prior
hormonal therapy at least 14 days prior to registration.

- Patients may receive concomitant bisphosphonate therapy for bone metastasis.

- Patients must have recovered from any prior surgery. Two weeks must have elapsed from
the time of any minor surgery and 4 weeks of any major surgery.

- Patients must have adequate bone marrow reserve as evidenced by the following: ANC >
1500/mcL, platelets > 100, 000/mcL, and hemoglobin > 9.0 gm/dL. These results must be
obtained within 28 days prior to registration.

- Patients must have serum creatinine < 1.5 mg/dL, obtained within 28 days prior to

- Urine Protein: creatinine ratio ≥ 1.0 at screening.

- Patients must have adequate liver function.

- Patients must have a Zubrod performance status of 0-1.

Exclusion Criteria:

- Patients must not have tumors that carry HER-2 gene amplifications as determined by
(i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein
3+ level assessed by immunohistochemistry; or may have tumors that carry HER=2 gene
amplification and have had disease progression while on trastuzumab. Patients who
have previously been treated with trastuzumab must be off treatment at least 28 days
prior to registration.

- Patients must not have CNS metastasis, leptomeningeal disease or lymphatic pulmonary

- Patients must not have had prior therapy with gemcitabine or bevacizumab.

- Patient must not have major surgical procedure, open biopsy, or significant traumatic
injury within 28 days prior to start of treatment, anticipation of need for major
surgical procedure during the course of the study.

- Patients must not have received radiation to > 50% of the marrow-bearing bone.

- Patients must not have a history of significant symptomatic cardiac disease or left
ventricular ejection fraction (LVEF) < 50% of the institutional lower limit of normal
(ILLN). An isotope cardiac scan (MUGA) and ECG must be obtained within 28 days.

- Patients with uncontrolled hypertension are NOT eligible (BP>150/100).

- Patients must not have pr-existing clinically significant (Grade 2 or greater per
CTCAE Version 3.0 motor or sensory neuropathy except for abnormalities due to cancer.

- Patients known to be HIV positive.

- Patients must not be nursing or pregnant. Men and women of reproductive potential
must agree to use an effective contraceptive method.

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or Stage II cancer from which the patient has been disease free for 5 years.

- Patients must not have had a Stroke or Myocardial Infarction in the past 6 months.
Patients with unstable agina, significant peripheral vascular disease, history of
abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the
last 6 months should be excluded.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the progression-free survival in patients receiving biweekly Paclitaxel + Gemcitabine + Avastin as first-line therapy for metastatic breast cancer.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Kathleen Havlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

June 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Breast cancer
  • Breast Neoplasms



University of Cincinnati Dept. of Medicine, Div. Hem/Onc Cincinnati, Ohio  45267