Breast CancerPhase 2NCT00003165
Doxorubicin in Treating Women With Advanced Breast Cancer
A Phase 2 study testing doxorubicin-HPMA conjugate in people with Breast Cancer, run by University of Glasgow at 6 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different forms may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with advanced 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?
- doxorubicin-HPMA conjugate
- How many people
- 25 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Dec 1997to 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 proven advanced metastatic carcinoma of the breast Bidimensionally measurable disease No brain or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 10 g/dL Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 11.7 mg/dL AST/ALT no greater than 2 times upper limit of normal (5 times upper limit of normal in presence of liver metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No concurrent treatment for congestive cardiac failure Cardiac function within normal limits by MUGA or ECHO scan, if prior anthracycline therapy Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent nonmalignant systemic disease No active uncontrolled infection No prior history of malignant disease except: Squamous cell carcinoma of the skin Curatively treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunological therapy Chemotherapy: At least 1 prior chemotherapy regimen for advanced disease (including adjuvant therapy), but not more than 2 prior regimens At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Cumulative dose of prior epirubicin no greater than 450 mg/m2 Cumulative dose of prior doxorubicin no greater than 240 mg/m2 No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Low dose steroid therapy allowed if dose established at least 4 weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No concurrent experimental therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Cancer Research Campaign Clinical Trials Unit-Birmingham (CRCTU)
Birmingham, England, B15 2TT
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Weston Park Hospital
Sheffield, England, S1O 2SJ
About this study
Official title: A Phase II Trial of PK1 in Women With Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different forms may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the antitumor activity of doxorubicin-HPMA conjugate (PK1) in women with advanced breast cancer.
OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin-HPMA conjugate (PK1) by intravenous infusion once every 3 weeks. Patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease.
PROJECTED ACCRUAL: 14-25 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- doxorubicin-HPMA conjugate
- Keywords
- stage IV breast cancer, recurrent 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.
doxorubicin-HPMA conjugateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2004 (estimated)
- Study startDec 1997
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
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Chris Twelves, MD, BMedSci, FRCP, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003165
- Sponsor's protocol ID
- CDR0000065966
- Other IDs
- CRC-PHASE-II-PH2/038, EU-97028
- Status last verified
- Apr 2010
- First submitted
- 1 Nov 1999
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of PK1 in Women With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00003165
- Acronym / sponsor ID
- CDR0000065966
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Dec 1997
- First posted
- 30 Apr 2004 (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. Giving drugs in different forms may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer.
Detailed description
OBJECTIVES: I. Determine the antitumor activity of doxorubicin-HPMA conjugate (PK1) in women with advanced breast cancer.
OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin-HPMA conjugate (PK1) by intravenous infusion once every 3 weeks. Patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease.
PROJECTED ACCRUAL: 14-25 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 |
|---|---|---|
| doxorubicin-HPMA conjugate | 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 19 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.
Chris Twelves, MD, BMedSci, FRCP study chair
University of Glasgow
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 doxorubicin-HPMA conjugate in people with Breast Cancer, run by University of Glasgow at 6 sites in United Kingdom.
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 19 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 Kingdom. 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 19 Dec 2013.