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Vinorelbine in Treating Older Women With Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT00022152
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: vinorelbine tartrate Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the time to progression in patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.
  • Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy
Study Start Date : November 2001
Actual Primary Completion Date : March 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: vinorelbine

Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

Drug: vinorelbine tartrate



Primary Outcome Measures :
  1. objective response rate [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. time to progression [ Time Frame: Up to 5 years ]
  2. quality of life [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IV breast cancer
  • Eligible to receive first- or second-line chemotherapy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm in longest diameter
    • Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy
  • No untreated brain metastases

    • Current metastatic CNS disease allowed only if previously treated and clinically stable at study entry
  • No meningeal carcinomatosis
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 65 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN because of Gilbert's syndrome

Renal:

  • Creatinine no greater than 2 times ULN

Other:

  • No grade 2 or greater peripheral neuropathy
  • No other significant medical condition that would preclude study
  • No active infection within the past 2 weeks
  • No dysphagia or inability to swallow intact capsules

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No prior vinca alkaloids
  • At least 4 weeks since other prior chemotherapy and recovered

Endocrine therapy:

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to 25% or more of bone marrow
  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

  • At least 3 weeks since prior major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022152


Locations
Show Show 18 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Edith A. Perez, MD Mayo Clinic
Publications of Results:
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00022152    
Other Study ID Numbers: NCCTG-N003A
NCI-2012-02395 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000068790 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action