Metastatic Breast CancerPhase 2NCT00214864
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
A Phase 2 study testing docetaxel, capecitabine in people with Metastatic Breast Cancer, run by Cancer Research Network at 1 site in United States.
Trial summary
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- docetaxel, capecitabine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Jan 2006
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histopathologically proven metastatic breast cancer.
- Patients 18-75 years old
- Performance status: Karnofsky > 70%
- Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
- Adequate bone marrow, liver, renal and cardiac functions defined as:
- Ability to understand the study and give informed consent.
- Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible.
Who cannot join
- Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
- Patients who have received any anti-cancer investigational agent in the month prior to inclusion.
- Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
- Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
- Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Research Network, Inc.
Plantation, Florida, 33324
About this study
Official title: A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
Read the detailed description
Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained; by using agents with non-overlapping toxicity profiles, these responses can be achieved with less toxicity than maximally tolerated doses of single agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine.
The primary objective is to evaluate the overall response rate (complete and partial responses) according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced and/or metastatic breast cancer. The secondary objectives are to evaluate tolerability, time to tumor progression, and time to treatment failure of the combination of capecitabine and docetaxel.
- Conditions
- Metastatic Breast Cancer
- Being tested
- docetaxel, capecitabine
- Keywords
- Metastatic Breast Cancer, Taxotere (docetaxel), Xeloda (capecitabine)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel, capecitabineDrug
cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1\&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8
What is being measured
The primary outcome is the main question the study is designed to answer.
To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Charles L Vogel, MD, Principal investigator, Cancer Research Network, IncElizabeth Tan-Chiu, MD, Study chair, Cancer Research Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214864
- Sponsor's protocol ID
- CRN-003
- Status last verified
- Feb 2012
- First submitted
- 15 Sep 2005
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00214864
- Acronym / sponsor ID
- CRN-003
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Taxotere (docetaxel), Xeloda (capecitabine)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2002
- Primary completion
- Jan 2006 (actual)
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
Detailed description
Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained; by using agents with non-overlapping toxicity profiles, these responses can be achieved with less toxicity than maximally tolerated doses of single agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine.
The primary objective is to evaluate the overall response rate (complete and partial responses) according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced and/or metastatic breast cancer. The secondary objectives are to evaluate tolerability, time to tumor progression, and time to treatment failure of the combination of capecitabine and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients with histopathologically proven metastatic breast cancer.
- Patients 18-75 years old
- Performance status: Karnofsky > 70%
- Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
- Adequate bone marrow, liver, renal and cardiac functions defined as:
Key exclusion criteria (5 listed)
- Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
- Patients who have received any anti-cancer investigational agent in the month prior to inclusion.
- Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
- Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
- Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.
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 |
|---|---|---|
| docetaxel, capecitabinecohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1\&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8 | Drug | – |
Primary outcome
To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination
Time frame: 2 years
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 14 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.
Charles L Vogel, MD principal investigator
Cancer Research Network, Inc
Elizabeth Tan-Chiu, MD study chair
Cancer Research Network, Inc.
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 docetaxel, capecitabine in people with Metastatic Breast Cancer, run by Cancer Research Network 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?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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 14 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 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 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.
What does the primary outcome measure?
To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 14 Feb 2012.