Breast CancerPhase 1/2NCT00006108
Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
A Phase 1/2 study testing trastuzumab, capecitabine and paclitaxel in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab, capecitabine and paclitaxel
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jul 2002
- Phase
- Phase 1/2
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease HER2 overexpressing tumor (2+ or 3+) Bidimensionally measurable or evaluable disease Hormone receptor status: Estrogen receptor positive or negative
PATIENT CHARACTERISTICS: Age: 18 to 59 Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction at least 50% by MUGA No history of congestive heart failure No uncontrolled cardiac arrhythmias Other: No other prior malignancy except squamous cell or basal cell carcinoma of the skin, noninvasive ductal carcinoma of the breast, or cervical dysplasia No prior motor or sensory neuropathy grade 2 or higher Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior trastuzumab (Herceptin) No concurrent hematopoietic growth factors Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed (including regimens containing doxorubicin) No prior paclitaxel, 24 hour infusion fluorouracil, or capecitabine Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 50% or more of the bone marrow Surgery: Not specified Other: No other concurrent experimental drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
About this study
Official title: A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast cancer. II. Determine the response rate of these patients to this treatment regimen. III. Determine the median time to treatment failure in these patients with this treatment regimen. IV. Determine the incidence of cardiac toxicity in these patients with this treatment regimen. V. Assess the quality of life in these patients.
OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2; and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is assessed at baseline and after 3 courses of treatment.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study. A total of 28-41 patients will be accrued for the phase II portion of this study.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, capecitabine, paclitaxel
- 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.
trastuzumabBiological
capecitabineDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2004 (estimated)
- Study startAug 1999
- Primary completionSep 2001
- Study completionJul 2002
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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frances A. Collichio, MD, Study chair, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006108
- Sponsor's protocol ID
- LCCC 9904
- Other IDs
- UNC-9904, NCI-G00-1834, CDR0000068119
- Status last verified
- Feb 2012
- First submitted
- 3 Aug 2000
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00006108
- Acronym / sponsor ID
- LCCC 9904
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1999
- Primary completion
- Sep 2001 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 26 Feb 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast cancer. II. Determine the response rate of these patients to this treatment regimen. III. Determine the median time to treatment failure in these patients with this treatment regimen. IV. Determine the incidence of cardiac toxicity in these patients with this treatment regimen. V. Assess the quality of life in these patients.
OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2; and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is assessed at baseline and after 3 courses of treatment.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study. A total of 28-41 patients will be accrued for the phase II portion of this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| trastuzumab | Biological | – |
| capecitabine | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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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.
Frances A. Collichio, MD study chair
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing trastuzumab, capecitabine and paclitaxel in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center 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: finished, as of the sponsor's last update on 7 Feb 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 7 Feb 2012.