NCT00006682

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in treating women who have metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2000

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

February 1, 2000

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2002

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
Last Updated

August 14, 2020

Status Verified

May 1, 2001

Enrollment Period

2 years

First QC Date

December 6, 2000

Last Update Submit

August 12, 2020

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

docetaxelDRUG

Docetaxel 70mg/m2 on day 1 of every 21-day cycle

Also known as: Taxotere
vinorelbine ditartrateDRUG

Navelbine 20mg/m2 on Day 1 and D8 of a 21-day cycle

Also known as: Navelbine

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV breast cancer Disease progression following prior adjuvant chemotherapy (no disease progression during treatment with prior doxorubicin) Bidimensionally measurable disease Prior radiotherapy allowed if disease completely outside radiation port or histologic evidence of measured area indicating malignancy and not radiation fibrosis No CNS metastases Brain metastases previously treated with radiotherapy or surgical excision allowed if no evidence of residual metastases on brain CT or MRI Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: ECOG 0-1 Life expectancy: Greater than 16 weeks Hematopoietic: WBC at least 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Not specified Cardiovascular: No symptomatic New York Heart Association class II or greater congestive heart failure No significant arrhythmia requiring drug therapy No myocardial infarction within the past 6 months No uncontrolled cardiac disease or unstable angina Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No preexisting clinically significant peripheral neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel) No unstable, preexisting medical condition No serious active infection No other underlying medical, psychological, familial, sociologic, or geographic condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior hematopoietic growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 7 days since prior platelet transfusion Chemotherapy: See Disease Characteristics No prior vinca alkaloids (including vinorelbine or docetaxel) No other concurrent antineoplastic agents Endocrine therapy: No concurrent anticancer hormonal agents Radiotherapy: See Disease Characteristics No concurrent palliative radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational drug or device

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

Sponsors & Collaborators

Study Sites (2)

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • David J. Perry, MD

    Medstar Health Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-Label Navelbine (vinorelbine tartrate) and Taxotere (docetaxel) as First-Line Therapy for Metastatic Breast Cancer
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2000

First Posted

May 4, 2004

Study Start

February 1, 2000

Primary Completion

January 22, 2002

Study Completion

January 22, 2002

Last Updated

August 14, 2020

Record last verified: 2001-05

Locations

US(2)