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Anti-metabolites
Liposomal Doxorubicin + Gemcitabine for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Pharmatech Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sex: Female
No anthracycline resistance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well combining liposomal doxorubicin with gemcitabine works in treating patients with breast cancer that has spread to other parts of the body.
Who is the study for?
This trial is for women with metastatic breast cancer who have not had uncontrolled seizures or infections, no recent other cancers except certain skin cancers and cervical carcinoma in situ, are not pregnant/nursing, and agree to use contraception. They should have received no more than one prior treatment for metastatic disease and must have a Karnofsky performance status of 60-100%. Participants need proper kidney and liver function, specific blood cell counts within range, a life expectancy of at least 3 months, limited prior anthracycline therapy, and no severe cardiac issues.Check my eligibility
What is being tested?
The study is testing the combination of two chemotherapy drugs: liposomal doxorubicin and gemcitabine. The goal is to see how effective this combo is in treating women with advanced breast cancer that has spread beyond the initial tumor site.See study design
What are the potential side effects?
Potential side effects include fatigue; nausea; hair loss; mouth sores; low blood cell counts leading to increased infection risk, bleeding or bruising easily; heart problems; liver or kidney issues. Each patient may experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
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My cancer is not resistant to anthracycline drugs.
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I have had only one treatment for my cancer after it spread.
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My blood counts meet the required levels and my bone marrow functions properly.
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My liver tests are within normal limits.
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My kidney function is normal, with creatinine levels at or below 2.5 mg/dL or my creatinine clearance is 60 mL/min or more.
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I have never been treated with Herceptin.
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I have received anthracycline treatment, but not more than 320 mg/m^2.
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I haven't had radiation on more than a third of my bone marrow areas.
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I haven't had heart disease in the last 5 years or my heart's pumping ability is at least 50%.
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I do not have any infections that aren't responding to treatment.
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My breast cancer has spread and can be measured.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
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I have not had seizures that were uncontrolled.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
Pharmatech OncologyLead Sponsor
4 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Breast Cancer
Sandy MarcusStudy ChairPharmatech Oncology
1 Previous Clinical Trials
1 Trials studying Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am female.My cancer is not resistant to anthracycline drugs.I haven't had any cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.I have had only one treatment for my cancer after it spread.My blood counts meet the required levels and my bone marrow functions properly.My liver tests are within normal limits.My kidney function is normal, with creatinine levels at or below 2.5 mg/dL or my creatinine clearance is 60 mL/min or more.I have never been treated with Herceptin.I have received anthracycline treatment, but not more than 320 mg/m^2.I haven't had radiation on more than a third of my bone marrow areas.I haven't had heart disease in the last 5 years or my heart's pumping ability is at least 50%.I do not have any infections that aren't responding to treatment.My breast cancer has spread and can be measured.I am 18 years old or older.I can care for myself but may not be able to do active work.I have not had seizures that were uncontrolled.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities have been enlisted to conduct this trial?
"Montgomery Cancer Center in Montgomery, Alabama, Pharmatech Oncology in Denver, Colorado, and Oncology-Hematology Associates, P.A. in Clinton, Maryland are the primary trial locations for this study; however there are also 5 supplementary sites that patients can choose from."
Answered by AI
Is enrollment still available for this investigation?
"This study, as evidenced by its last update in 2013 on clinicaltrials.gov, is no longer actively seeking participants. However, there are 2,600 other studies that are still looking to expand their patient pool."
Answered by AI
Does this intervention have governmental authorization?
"The safety rating for this intervention is a 2 due to the fact that, as it's only in Phase 2 of its clinical trials, data exists regarding its security but not yet about how effective it is."
Answered by AI
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