BreastPhase 1/2NCT00277069
Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
A Phase 1/2 study testing Carboplatin, Capecitabine and Vinorelbine in people with Breast and Cancer, run by University of New Mexico at 1 site in United States.
Trial summary
1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- What is being tested?
- Carboplatin, Capecitabine and Vinorelbine
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Mar 2006
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a histological diagnosis of breast cancer with metastasis.
- The metastatic disease should be confirmed by biopsy if clinically indicated.
- The patient must have measurable or evaluable disease.
- Age > 18 years and < 75 years.
- The patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum.
- The patient may have received herceptin previously.
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- The patients must have previously received at least one cycle of chemotherapy.
- The patient must have received anthracycline and taxane containing chemotherapy in the past. This may be either in the adjuvant setting or for metastatic disease. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse/progression within 6 months of completing chemotherapy.
- Performance status < 2.
- At least 3 weeks must have elapsed since the completion of prior radiation therapy, chemotherapy, or hormonal therapy. The patient must have recovered from all grade 3-4 associated toxicities at the time of registration. Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present.
- Patients must not receive concurrent hormonal, or biologic therapy, or radiation therapy to measurable or evaluable disease.
- The patient should not have uncontrolled CNS disease.
- Laboratory parameters: ANC > l500/ l, Platelets >100 000/ l, creatinine < 2.0, bilirubin < 2.0
- Informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
Read the detailed description
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
- Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
- Determine the time to relapse after the administration of this regimen.
- Being tested
- Carboplatin, Capecitabine, Vinorelbine
- Keywords
- Breast metastatic
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
CapecitabineDevice
Also called Xeloda
Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days
VinorelbineDrug
Also called Navelbine
Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study.
Measured: disease progression or unacceptable toxicities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startMay 2000
- Primary completionMar 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Ian Rabinowitz, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277069
- Sponsor's protocol ID
- 2899C
- Status last verified
- Oct 2008
- First submitted
- 12 Jan 2006
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00277069
- Acronym / sponsor ID
- 2899C
- Keywords
- Breast metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 13 Jan 2006 (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.
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
Detailed description
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
- Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
- Determine the time to relapse after the administration of this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (14 listed)
- Patient must have a histological diagnosis of breast cancer with metastasis.
- The metastatic disease should be confirmed by biopsy if clinically indicated.
- The patient must have measurable or evaluable disease.
- Age > 18 years and < 75 years.
- The patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CarboplatinCarboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days | Drug | – |
| CapecitabineAlso: XelodaCapecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 days | Device | – |
| VinorelbineAlso: NavelbineVinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 days | Drug | – |
Primary outcome
Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study.
Time frame: disease progression or unacceptable toxicities
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 Jan 2010.
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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.
Ian Rabinowitz, MD principal investigator
University of New Mexico
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 Carboplatin, Capecitabine and Vinorelbine in people with Breast and Cancer, run by University of New Mexico 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 14 inclusion and 0 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 7 Jan 2010. 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.
What does the primary outcome measure?
Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study. (time frame: disease progression or unacceptable toxicities). 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 7 Jan 2010.