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Anti-tumor antibiotic

Doxil + Vinorelbine for Breast Cancer

Phase 2
Waitlist Available
Led By Leslie R Laufman, MD
Research Sponsored by Hematology Oncology Consultants
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 weeks
Women 18 years or older with biopsy proven advanced breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of a two-drug combination (Doxil and vinorelbine) given every 28 days to women with metastatic breast cancer.

Who is the study for?
This trial is for women over 18 with advanced breast cancer that has spread, who have a good performance status and haven't had excessive prior chemotherapy. They must not be pregnant or breastfeeding, agree to use contraception, and have no severe heart conditions or hypersensitivity to the drugs being tested.Check my eligibility
What is being tested?
The study tests Doxil given on day 1 and Vinorelbine on days 1 and 2 of a 28-day cycle in patients with metastatic breast cancer. It aims to evaluate the safety and effectiveness of this combination therapy.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations, and possible heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 with advanced breast cancer confirmed by biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Overall survival
Time to progression
Toxicity

Find a Location

Who is running the clinical trial?

Hematology Oncology ConsultantsLead Sponsor
Ortho Biotech, Inc.Industry Sponsor
31 Previous Clinical Trials
2,415 Total Patients Enrolled
1 Trials studying Breast Cancer
102 Patients Enrolled for Breast Cancer
Leslie R Laufman, MDPrincipal InvestigatorHematology Oncology Consultants, Inc

Media Library

Doxil (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00159094 — Phase 2
Breast Cancer Research Study Groups:
Breast Cancer Clinical Trial 2023: Doxil Highlights & Side Effects. Trial Name: NCT00159094 — Phase 2
Doxil (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00159094 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks might patients endure with this therapeutic procedure?

"This particular intervention has been assigned a score of 2 on our safety scale, as it is currently in Phase Two trials. This implies that there are clinical data confirming its security but not yet any evidence validating its efficacy."

Answered by AI

Is enrollment currently available for this research project?

"Per the information available on clinicaltrials.gov, this medical trial is no longer enrolling patients; the investigation was initially posted in October 2003 and the most recent update occurred on May 30th 2008. However, there are presently 2297 other studies that need volunteers for their trials."

Answered by AI
~1 spots leftby Mar 2025