Breast CancerPhase 2NCT00028483
Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
A Phase 2 study testing cBR96-doxorubicin immunoconjugate and docetaxel in people with Breast Cancer, run by Seagen Inc. at 1 site 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. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. 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?
- cBR96-doxorubicin immunoconjugate and docetaxel
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Apr 2003
- 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 confirmed metastatic or recurrent breast carcinoma
- Unresectable disease
- Previously treated with no more than 2 chemotherapy regimens for metastatic disease OR
- Recurrent within 6 months of adjuvant chemotherapy
- Must have one of the following:
- Measurable disease
- Positive bone scan and elevation of serum tumor marker for adenocarcinoma
- Serum levels must have increased over 2 consecutive measurements and exceed at least 2 times upper limit of normal
- Lewis-y antigen expression documented by immunohistochemistry
- No brain metastases that are uncontrolled or require active treatment (including steroids)
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 10 g/dL
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2.5 times normal
- Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis present)
- Amylase/lipase less than 1.5 times normal
- Hepatitis B and C negative
- No hepatic failure
Renal:
- Creatinine no greater than 1.5 times upper limit of normal
- No renal failure
Cardiovascular:
- LVEF greater than 50% by echocardiogram or MUGA scan
- No congestive heart failure
Other:
- HIV negative
- No antibody present that detects monoclonal antibody BR96 in serum
- No peripheral neuropathy grade 2 or greater
- No dementia or altered mental status
- No other serious underlying medical condition that would preclude study participation
- No prior allergic reactions to recombinant human or murine proteins
- No uncontrolled peptic ulcer disease
- No active viral, bacterial, or systemic fungal infections
- No other primary malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No serious nonmalignant disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 8 weeks since prior therapeutic or diagnostic murine/humanized/human chimeric antibodies
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, mitomycin, or anthracyclines)
- No prior cumulative anthracycline of 300 mg/m2 or more
- No concurrent antineoplastic agents
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since prior hormonal therapy
- No concurrent hormonal therapy except estrogen replacement
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No other concurrent experimental agents
- No concurrent immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
About this study
Official title: A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) and docetaxel in women with metastatic or recurrent breast cancer.
- Determine the clinical response rate and duration of response of patients treated with this regimen.
OUTLINE: Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 18-24 months.
- Conditions
- Breast Cancer
- Being tested
- cBR96-doxorubicin immunoconjugate, docetaxel
- 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.
cBR96-doxorubicin immunoconjugateDrug
docetaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2003 (estimated)
- Study startOct 2000
- Study completionApr 2003
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
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lisle M. Nabell, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028483
- Sponsor's protocol ID
- CDR0000069079
- Other IDs
- SGEN-UAB-9912, UAB-9912
- Status last verified
- Oct 2011
- First submitted
- 4 Jan 2002
- Last updated
- 24 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
- ClinicalTrials.gov ID
- NCT00028483
- Acronym / sponsor ID
- CDR0000069079
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2000
- Study completion
- Apr 2003 (actual)
- First posted
- 27 Jun 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. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer.
Detailed description
OBJECTIVES:
- Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) and docetaxel in women with metastatic or recurrent breast cancer.
- Determine the clinical response rate and duration of response of patients treated with this regimen.
OUTLINE: Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 18-24 months.
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 |
|---|---|---|
| cBR96-doxorubicin immunoconjugate | Drug | – |
| docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
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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.
Lisle M. Nabell, MD study chair
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cBR96-doxorubicin immunoconjugate and docetaxel in people with Breast Cancer, run by Seagen Inc. at 1 site 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: stopped early, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early. 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 24 Oct 2011.