Vinorelbine in Treating Older Women With Stage IV Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022152
• Other study ID #: NCCTG-N003A
• Secondary ID: NCI-2012-02395CD
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: July 1, 2016
• Start date: November 2001
• Est. completion date: August 2007

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• vinorelbine tartrate

Locations

Country	Name	City	State
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	Altru Health Systems	Grand Forks	North Dakota
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Health Plaza	Saint Cloud	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baweja M, Suman VJ, Fitch TR, Mailliard JA, Bernath A, Rowland KM, Alberts SR, Kaur JS, Perez EA; NCCTG. Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients > or = 65 years of age: an NCCTG study. Ann Oncol. 2006 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		Up to 5 years	No
Secondary	time to progression		Up to 5 years	No
Secondary	quality of life		Up to 5 years	No