Clinical trial NCT00022152: Vinorelbine in Treating Older Women With Stage IV Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: objective response rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: time to progression
timeFrame: Up to 5 years
measure: quality of life
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Health Plaza
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health Systems
state: North Dakota
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
Study officials:
affiliation: Mayo Clinic
name: Edith A. Perez, MD
role: STUDY_CHAIR
References:
citation: 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 Apr;17(4):623-9. doi: 10.1093/annonc/mdj130. Epub 2006 Mar 6.