NCT00159094

Brief Summary

This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer.

Trial Health

55
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Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

June 2, 2008

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

May 30, 2008

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (3)

  • Time to progression

  • Overall survival

  • Toxicity

Interventions

Doxil and VinorelbineDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be informed of the investigational nature of this study and must give and sign informed consent in compliance with federal and institutional guidelines.
  • Women 18 years or older with biopsy proven advanced breast cancer.
  • Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment.
  • Performance status (PS) 0-2 (ECOG). PS must be 0-1 if patient has had more than one prior regimen for metastatic disease or more than 2 prior regimens, including adjuvant and metastatic.
  • Measurable disease by RECIST criteria, with baseline staging completed within 14 days of registration.
  • At least two weeks post surgery and three weeks from completion of irradiation and recovered from toxicities associated with these treatments.
  • Psychological, family, social and geographical conditions allowing weekly medical follow up during chemotherapy are required.
  • Preregistration blood work must include complete blood counts with differential, and blood chemistries including serum bilirubin, GGT, LDH, SGOT, SGPT, alkaline phosphatase, creatinine, and tumor markers, CEA and CA 27-29. Patients must have:
  • Absolute neutrophil count (ANC) \>1,500/mm3
  • Platelet count \>100,000/mm3
  • Hemoglobin \> 8.0 g/dl
  • Serum creatinine \< 2.5 mg/dl (\< 200 mol/L)
  • Serum bilirubin \< the upper limit of normal (ULN)
  • SGOT and SGPT or AST and ALT \< 2.0 x ULN
  • Alkaline phosphatase \< 2.0 x ULN, except if attributed to tumor
  • +1 more criteria

You may not qualify if:

  • Prior Doxil® or vinorelbine
  • Cumulative anthracycline dose exceeding 400 mg/m2 anthracycline
  • Primary anthracycline refractory disease, ie. disease progression during treatment or relapse/recurrence within 6 months after last dose of anthracycline
  • If PS 0-1, more than 3 prior chemotherapy regimens, including adjuvant and metastatic
  • If PS 2, more than 1 prior regimen for metastatic disease or more than 2 prior chemotherapy regimens, including adjuvant and metastatic
  • Hormone therapy including aromatase inhibitors within 2 weeks of baseline
  • Pregnant or lactating women. Women of reproductive potential must have a negative pregnancy test and must agree to use an effective contraceptive method
  • Prior history of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure
  • Symptomatic brain metastasis
  • Past medical history of severe hypersensitivity reaction to conventional formulation of doxorubicin HCL or the components of Doxil® or vinorelbine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hematology Oncology Consultants, Inc

Columbus, Ohio, 43235, United States

RECRUITING

Hematology Oncology Consultants, Inc

Newark, Ohio, 43055, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinVinorelbine

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

  • Leslie R Laufman, MD

    Hematology Oncology Consultants, Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie R Laufman, MD

CONTACT

614-846-0044email@hoci.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

October 1, 2003

Last Updated

June 2, 2008

Record last verified: 2005-09

Locations

US(2)