NCT00022152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2001

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2001

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

August 10, 2001

Last Update Submit

July 1, 2016

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    Up to 5 years

Secondary Outcomes (2)

  • time to progression

    Up to 5 years

  • quality of life

    Up to 5 years

Study Arms (1)

vinorelbine

EXPERIMENTAL

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

Interventions

vinorelbine tartrateDRUG
vinorelbine

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (18)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related 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 Apr;17(4):623-9. doi: 10.1093/annonc/mdj130. Epub 2006 Mar 6.

    PMID: 16520332RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Edith A. Perez, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

March 1, 2006

Study Completion

August 1, 2007

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

US(18)