Breast CancerPhase 2NCT00027989
Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
A Phase 2 study testing gemcitabine hydrochloride and pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer, run by Pharmatech Oncology at 6 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gemcitabine hydrochloride and pegylated liposomal doxorubicin hydrochloride
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Dec 2001to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic breast cancer
- Measurable disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
- Absolute neutrophil count at least 1,500/mm^3
- No impaired bone marrow function
Hepatic:
- Bilirubin no greater than 2 mg/dL
- AST and ALT no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor)
- No impaired hepatic function
Renal:
- Creatinine no greater than 2.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No impaired renal function
Cardiovascular:
- No prior cardiac disease within the past 5 years OR
- LVEF at least 50%
Other:
- No prior uncontrolled seizures
- No uncontrolled systemic infection
- No anthracycline resistance
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior trastuzumab (Herceptin)
Chemotherapy:
- Prior adjuvant therapy with anthracycline of no more than 320 mg/m^2 allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to more than 1/3 of hematopoietic sites
Surgery:
- Not specified
Other:
- At least 30 days since prior investigational medications and recovered
- No more than 1 prior treatment regimen for metastatic disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735
South Carolina Oncology Associates
Columbia, South Carolina, 29201
South Carolina Oncology Associates
Columbia, South Carolina, 29203
Pharmatech Oncology
Denver, Colorado, 80203
Montgomery Cancer Center
Montgomery, Alabama, 36106
California Cancer Medical Center
West Covina, California, 91790
About this study
Official title: An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine.
- Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.
Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.
Patients are followed at 4 weeks and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride
- Keywords
- stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Pharmatech Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sandy Marcus, Study chair, Pharmatech Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027989
- Sponsor's protocol ID
- CDR0000069104
- Other IDs
- PHARMATECH-P01-00002008, ORTHO-PHARMATECH-P01-000020008, PHARMATECH-20002183
- Status last verified
- Apr 2004
- First submitted
- 7 Dec 2001
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00027989
- Acronym / sponsor ID
- CDR0000069104
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Pharmatech OncologyIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine.
- Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.
Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.
Patients are followed at 4 weeks and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandy Marcus study chair
Pharmatech Oncology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride and pegylated liposomal doxorubicin hydrochloride in people with Breast Cancer, run by Pharmatech Oncology at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.