Metastatic Breast CancerPhase 2NCT00216073
Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
A Phase 2 study testing Capecitabine, Oxaliplatin and Trastuzumab in people with Metastatic Breast Cancer, run by Hoosier Cancer Research Network at 11 sites in United States.
Trial summary
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2004to Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.·
- HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry will not be sufficient for entry.·
- At least one measurable lesion as defined by the RECIST.
- Prior hormonal therapy for metastatic disease is allowed.
- Maximum of one prior chemotherapy regimen or trastuzumab-containing regimen for unresectable, locally recurrent or metastatic disease
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
Who cannot join
- No prior therapy with capecitabine or oxaliplatin in any setting
- No prior therapy with other platinum compounds·
- No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to beginning protocol therapy.·
- No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.·
- No prior fluoropyrimidine therapy for metastatic disease is allowed.
- Prior adjuvant fluoropyrimidine therapy is allowed if completed > 12 months from study entry.·
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- No symptomatic brain metastasis. ·
- No evidence of serious concomitant systemic disorders incompatible with the study ·
- No peripheral neuropathy ·
- No major surgery within 28 days prior to beginning protocol therapy.·
- Negative pregnancy test·
- No current breastfeeding·
- No malabsorption syndrome·
- No evidence of serious concomitant systemic disorders incompatible with the study·
- Patients must not be treated with any of the following while on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Elkhart Clinic
Elkhart, Indiana, 46515
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Community Regional Cancer Center
Indianapolis, Indiana, 46256
Center for Hematology/Oncology of S. Michigan
Jackson, Michigan, 49201
Medical Consultants, P.C.
Muncie, Indiana, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
AP&S Clinic
Terre Haute, Indiana, 47804
About this study
Official title: A Phase II Trial of Capecitabine, Oxaliplatin and Trastuzumab (CAPOX-T) in Patients With HER-2 Positive Metastatic Breast Cancer: Hoosier Oncology Group BRE03-61
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds. Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer. This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.
Read the detailed description
OUTLINE: This is a multi-center study.
- CAPOX-T (21 day cycle):Capecitabine 825 mg/m2 orally twice daily Days 1-14Oxaliplatin 100 mg/m2 intravenously Day 1
- Trastuzumab : 6 mg/kg intravenously Day 1.8mg/kg loading dose should be given in cycle 1 for patients without previous trastuzumab therapy only.
Patients may continue combination therapy until progression or toxicity intervenes. Patients who discontinue either or both cytotoxic agents due to toxicity may, at the investigators discretion, continue therapy with the remaining agents on study until progressive disease
ECOG performance status 0 or 1
Hematopoietic:·
- ANC > 1,200/mm3·
- Platelets > 100,000/mm3
Hepatic:·
- Total bilirubin < 1.5 x ULN·
- AST < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:·
- Serum creatinine < 1.5 x ULN and estimated creatinine clearance >50ml/min as calculated with Cockroft-Gault equation
Cardiovascular:·
- No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.·
- LVEF > LLN by MUGA or ECHO
- Conditions
- Metastatic Breast Cancer
- Being tested
- Capecitabine, Oxaliplatin, Trastuzumab
- Keywords
- 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.
CapecitabineDrug
Capecitabine 825 mg/m2 po bid, days 1-14
OxaliplatinDrug
Oxaliplatin 100 mg/m2 IV, day 1
TrastuzumabDrug
Trastuzumab 6mg/kg IV, day 1. 8 mg/kg loading dose given in cycle 1 for patients without previous trastuzumab therapy only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Capecitabine + Oxaliplatin + trastuzumab. Patients must be HER2 positive. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
- · To determine the objective response rate (CR+PR) of capecitabine, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer.
Measured: 18 months
Secondary outcomes (4)
To measure time to progression
Measured: 18 months
To determine rate of clinical benefit response (CR + PR + SD > 6 months)
Measured: 18 months
To determine toxicity rate of CAPOX-T in this patient population
Measured: 18 months
To explore potential correlations between changes in HER2 circulating extracellular domain in the primary tumor with response
Measured: 18 months
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 startMar 2004
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: Lack of patient accrual
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Hoffmann-La Roche, Walther Cancer Institute
- Investigators
- Kathy Miller, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216073
- Sponsor's protocol ID
- HOG BRE03-61
- Status last verified
- Apr 2011
- First submitted
- 9 Sep 2005
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Capecitabine, Oxaliplatin and Trastuzumab (CAPOX-T) in Patients With HER-2 Positive Metastatic Breast Cancer: Hoosier Oncology Group BRE03-61
- ClinicalTrials.gov ID
- NCT00216073
- Acronym / sponsor ID
- HOG BRE03-61
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Sanofi, Hoffmann-La Roche, Walther Cancer Institute
- Study start
- Mar 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 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.
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds. Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer. This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.
Detailed description
OUTLINE: This is a multi-center study.
- CAPOX-T (21 day cycle):Capecitabine 825 mg/m2 orally twice daily Days 1-14Oxaliplatin 100 mg/m2 intravenously Day 1
- Trastuzumab : 6 mg/kg intravenously Day 1.8mg/kg loading dose should be given in cycle 1 for patients without previous trastuzumab therapy only.
Patients may continue combination therapy until progression or toxicity intervenes. Patients who discontinue either or both cytotoxic agents due to toxicity may, at the investigators discretion, continue therapy with the remaining agents on study until progressive disease
ECOG performance status 0 or 1
Hematopoietic:·
- ANC > 1,200/mm3·
- Platelets > 100,000/mm3
Hepatic:·
- Total bilirubin < 1.5 x ULN·
- AST < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:·
- Serum creatinine < 1.5 x ULN and estimated creatinine clearance >50ml/min as calculated with Cockroft-Gault equation
Cardiovascular:·
- No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.·
- LVEF > LLN by MUGA or ECHO
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Capecitabine, Drug: Oxaliplatin, Drug: TrastuzumabCapecitabine + Oxaliplatin + trastuzumab. Patients must be HER2 positive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.·
- HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry will not be sufficient for entry.·
- At least one measurable lesion as defined by the RECIST.
- Prior hormonal therapy for metastatic disease is allowed.
- Maximum of one prior chemotherapy regimen or trastuzumab-containing regimen for unresectable, locally recurrent or metastatic disease
Key exclusion criteria (15 listed)
- No prior therapy with capecitabine or oxaliplatin in any setting
- No prior therapy with other platinum compounds·
- No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to beginning protocol therapy.·
- No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.·
- No prior fluoropyrimidine therapy for metastatic disease is allowed.
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 |
|---|---|---|
| CapecitabineCapecitabine 825 mg/m2 po bid, days 1-14 | Drug | 1 |
| OxaliplatinOxaliplatin 100 mg/m2 IV, day 1 | Drug | 1 |
| TrastuzumabTrastuzumab 6mg/kg IV, day 1. 8 mg/kg loading dose given in cycle 1 for patients without previous trastuzumab therapy only. | Drug | 1 |
Primary outcome
- · To determine the objective response rate (CR+PR) of capecitabine, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer.
Time frame: 18 months
4 secondary outcomes
To measure time to progression
Time frame: 18 months
To determine rate of clinical benefit response (CR + PR + SD > 6 months)
Time frame: 18 months
To determine toxicity rate of CAPOX-T in this patient population
Time frame: 18 months
To explore potential correlations between changes in HER2 circulating extracellular domain in the primary tumor with response
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Lack of patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
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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.
Kathy Miller, M.D. study chair
Hoosier Oncology Group, LLC
11 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 Capecitabine, Oxaliplatin and Trastuzumab in people with Metastatic Breast Cancer, run by Hoosier Cancer Research Network at 11 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?
The sponsor lists 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study was stopped early (reason given: Lack of patient accrual). 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.
What does the primary outcome measure?
- · To determine the objective response rate (CR+PR) of capecitabine, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer. (time frame: 18 months). 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 2 May 2011.