Recruiting
Phase 2

Doxil & Vinorelbine

Sponsor:

Hematology Oncology Consultants

Code:

NCT00159094

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxil and Vinorelbine

Study Details

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.

Conditions

Metastatic Breast Cancer

Study ID

NCT00159094

Start date

Oct, 2003

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Life expectancy > than 12 week.

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Doxil and Vinorelbine

Primary outcome measure

  • Response rate [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Leslie R Laufman, MD

614-846-0044email@hoci.org

Locations

Hematology Oncology Consultants, Inc

Recruiting

Columbus, Ohio, United States, 43235

Contacts

Debbie Conover, RN

614-846-0044debbie@hoci.org

Principal Investigator:

Leslie R Laufman, MD

Hematology Oncology Consultants, Inc

Recruiting

Newark, Ohio, United States, 43055

Contacts

Heather Meek

740-344-5705heather@hoci.org

Principal Investigator:

Leslie R Laufman, MD

More Information

Sponsor

Hematology Oncology Consultants

Last update posted

Jun 2, 2008

Last verified

Sep, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hematology Oncology Consultants on 2008-06-02.