Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00662129
First received: April 18, 2008
Last updated: June 17, 2012
Last verified: March 2010
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: bevacizumab
Drug: gemcitabine hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month progression-free survival (PFS) rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • PFS time [ Designated as safety issue: No ]
  • Confirmed response (complete or partial response) [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: November 2008
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab.

Secondary

  • To determine the adverse event profile of this regimen.
  • To determine the progression-free survival and overall survival of patients treated with this regimen.
  • To determine the confirmed response rate, duration of response, and time to treatment failure in patients treated with this regimen.
  • To determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed infiltrating breast cancer

    • Clinical evidence of metastatic disease
  • Measurable disease, defined as at least one measurable lesion per RECIST criteria

    • No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab
  • No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan

    • CNS metastasis controlled by prior surgery and/or radiotherapy allowed

      • Must be asymptomatic for ≥ 2 months with no evidence of progression prior to study entry
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Life expectancy ≥ 12 weeks
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 mg/dL
  • Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein

    • Patients discovered to have ≥ 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study therapy
  • Able to complete questionnaires alone or with assistance
  • No peripheral neuropathy > grade 1
  • No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents
  • No stage III or IV invasive, non-breast malignancy within the past 5 years
  • No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix

    • Patient must not be receiving other specific treatment for a prior malignancy
  • No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2 occasions at least 5 minutes apart)

    • Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for ≥ 3 different observations in ≥ 14 days
  • No bleeding diathesis or uncontrolled coagulopathy
  • No hemoptysis within the past 6 months
  • No prior arterial or venous thrombosis within the past 12 months
  • No history of cerebrovascular accident
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No abdominal fistula or gastrointestinal perforation within the past 6 months
  • No serious non-healing wound, ulcer, or fracture
  • No clinically significant cardiac disease, defined as any of the following:

    • Congestive heart failure
    • Symptomatic coronary artery disease
    • Unstable angina
    • Cardiac arrhythmias not well controlled with medication
    • Myocardial infarction within the past 12 months
  • No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy for metastatic disease

    • May have received one prior adjuvant chemotherapy regimen
  • Prior neoadjuvant chemotherapy allowed

    • More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy
  • Prior hormonal therapy in either adjuvant or metastatic setting allowed
  • More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)

    • Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed
  • More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug
  • More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)
  • More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy
  • More than 1 week since prior minor surgery (e.g., core biopsy)

    • Placement of a vascular access device within 7 days is allowed
  • More than 3 months since prior neurosurgery
  • No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered

    • Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662129

  Show 92 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Donald W. Northfelt, MD, FACP Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00662129     History of Changes
Other Study ID Numbers: CDR0000593581, NCCTG-N0735
Study First Received: April 18, 2008
Last Updated: June 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
male breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Bevacizumab
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014