Paclitaxel Poliglumex and Capecitabine in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00265733
First received: December 14, 2005
Last updated: June 17, 2012
Last verified: April 2007
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with capecitabine works in treating patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: paclitaxel poliglumex
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of confirmed tumor response (complete and partial response) as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: February 2006
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Assess the tumor response rate and adverse event profile in patients with metastatic, HER2 negative breast cancer treated with paclitaxel poliglumex (CT-2103; Xyotax™) and capecitabine.
  • Examine the distributions of disease-free progression times and survival times in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologic or cytologic confirmation of breast cancer with clinical evidence of metastatic disease

    • No bone metastases as the only evidence of metastasis
  • Measurable disease, defined as at least one measurable lesion

    • No non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 2.0 cm) and truly non-measurable lesions, which include the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
  • No known brain metastasis
  • HER2 negative disease by immunohistochemistry and/or fluorescent in situ hybridization
  • Diagnostic tissue and operative and pathology reports from breast cancer diagnosis and/or diagnosis of metastatic breast cancer must be available
  • Hormone receptor status

    • Not specified

PATIENT CHARACTERISTICS:

  • Males or females are eligible
  • Menopausal status: not specified
  • Life expectancy ≥ 3 months
  • ECOG performance status 0 or 1
  • Any serum estradiol level allowed
  • Hemoglobin > 8.0 g/dL
  • Absolute neutrophil count ≥ 1500/mL
  • Platelet count ≥ 100,000/mL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST and ALT ≤ 2.5 times UNL
  • Calcium normal
  • Creatinine clearance ≥ 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of childbearing potential or their sexual partners must be willing to employ adequate contraception (as determined by the treating physician) for the duration of the study and for 30 days after treatment has ended
  • No stage III or IV invasive, non-breast malignancies in ≤ 5 years prior to registration
  • No history of allergy or hypersensitivity to capecitabine, paclitaxel, or fluorouracil
  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No known DPD deficiency
  • No known, existing uncontrolled coagulopathy
  • No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
  • No lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medication
  • No significant medical condition that would make treatment or follow-up on this protocol difficult or problematic, in the opinion of the treating oncologist
  • No preexisting neuropathy > grade 0

PRIOR CONCURRENT THERAPY:

  • No other concurrent cytotoxic agents, investigational drugs, immunotherapy, radiation therapy or hormonal therapy
  • Capecitabine must not be administered together with antiviral drugs
  • No concurrent allopurinol, metronidazole, or sorivudine (or its chemically-related analogues, such as brivudine)
  • Cimetidine must be discontinued at least 2 weeks prior to start of study treatment and must be avoided while taking capecitabine
  • Patients receiving bisphosphonates are eligible for this study
  • No prior chemotherapy for metastatic disease
  • Prior anthracycline and/or taxane in the neoadjuvant or adjuvant setting allowed if completed ≥ 6 months prior to registration
  • Unlimited prior hormonal therapy allowed in the neoadjuvant, adjuvant, or metastatic setting
  • No HIV-positive individuals receiving combination anti-retroviral therapy
  • No major surgery, chemotherapy, or immunologic therapy ≤ 4 weeks prior to registration
  • No radiotherapy ≤ 4 weeks prior to registration, except to a non-target lesion only
  • Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed

    • If patient receives single dose radiation for palliation, they may immediately proceed to registration without waiting 4 weeks
  • Neoadjuvant and/or adjuvant therapy must be completed > 6 months prior to registration
  • No current or recent use (≤ 2 weeks prior to registration) of aspirin, anticoagulants or thrombolytic agents

    • Agents to maintain patency of a vascular access device is permitted
  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: NCT00265733

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Investigator: Edith A. Perez, MD Mayo Clinic
Investigator: Timothy Hobday, MD Mayo Clinic
Study Chair: Donald W. Northfelt, MD, FACP Mayo Clinic
Investigator: Daniel W. Visscher, MD Mayo Clinic
Investigator: Mark Rodacker, MD Medcenter One Hospital Cancer Care Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00265733     History of Changes
Other Study ID Numbers: CDR0000456449, NCCTG-N0437
Study First Received: December 14, 2005
Last Updated: June 17, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Capecitabine
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014