Metastatic Breast CancerPhase 1CELAVIENCT01238029
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
A Phase 1 study testing Lapatinib and Capecitabine and Vinorelbine in people with Metastatic Breast Cancer and HER2 Positive, run by Sponsor GmbH at 11 sites in Germany.
Trial summary
The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy
- What is being tested?
- Lapatinib and Capecitabine and Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 11 sitesGermany
- Study dates
- Oct 2010to Jul 2014
- Phase
- Phase 1
- 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
- Written informed consent
- Able to comply with the protocol
- ECOG performance status 0-1
- Adequate contraception
- Confirmed Her2/neu-positive, adenocarcinoma of the breast
- At least one measurable lesion according to RECIST 1.1 criteria
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- First or second chemotherapy after diagnosis of metastasis
- Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
- No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
- Adequate hepatic and renal function value
- Adequate hematologic function values
Who cannot join
- Pregnant or lactating women
- Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
- Asymptomatic with regards to tumor illness
- Previous treatment with lapatinib, capecitabine or vinorelbine
- Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
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- Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
- History of vascular or cardiovascular disease within the past 6 months
- All illnesses that result in malabsorption of oral medication or inability to take oral medication
- Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
- Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
- Concurrent treatment with allopurinol
- Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years
- Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Onkologische Gemeinschaftspraxis Dörfel/Göhler
Dresden, Saxony, 01127
Onkologische Schwerpunktpraxis
Goslar, Lower Saxony, 38642
Onkodok (Dr. Rösel und Dr. Depenbusch)
Gütersloh, North Rhine-Westphalia, 33332
Onkologische Schwerpunktpraxis
Heidelberg, 69115
Praxisgemeinschaft Dres. Siehl und Söling
Kassel, Hesse, 34117
Onkologische Schwerpunktpraxis Leer Emden
Leer, Lower Saxony, 26789
Praxis für Hämatologie und Onkologie
Mülheim, North Rhine-Westphalia, 45468
Hämatologisch-onkologische Gemeinschaftspraxis
Münster, North Rhine-Westphalia, 48149
Praxis für Onkologie u. Hämatologie
Neuss, North Rhine-Westphalia, 41462
Onkologie Ravensburg
Ravensburg, Baden-Wurttemberg, 88214
Schwerpunktpraxis Hämatologie / Onkologie
Stade, Lower Saxony, 21680
About this study
Official title: Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab
The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.
Read the detailed description
The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive metastatic breast cancer. This study combines this therapy with the additional antimitotic mode of function by vinorelbine.
- Conditions
- Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy, Failure or Contraindication of Trastuzumab Therapy
- Being tested
- Lapatinib and Capecitabine and Vinorelbine
- Keywords
- Dose finding study, Combination
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapatinib and Capecitabine and VinorelbineDrug
Also called Xeloda, Tyverb, Navirel
Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine, Lapatinib, Vinorelbine | Experimental | Not described Receives: Drug: Lapatinib and Capecitabine and Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)
Measured: 4 months
Secondary outcomes (4)
Overall response Rate
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Measured: 12 months
Progression free survival
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Measured: 12 months
Time to treatment failure (TTF)
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Measured: 12 months
Overall survival (OS)
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: new methods of treatment, no more patients appilicable for study
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sponsor GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- iOMEDICO AG, Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Ulrike Soeling, MD, Principal investigator, Goethestr. 47, 34119 , Kassel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238029
- Sponsor's protocol ID
- 0907-002
- Acronym
- CELAVIE
- Status last verified
- Nov 2014
- First submitted
- 2 Nov 2010
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab
- ClinicalTrials.gov ID
- NCT01238029
- Acronym / sponsor ID
- CELAVIE / 0907-002
- Conditions
- Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy, Failure or Contraindication of Trastuzumab Therapy
- Keywords
- Dose finding study, Combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new methods of treatment, no more patients appilicable for study
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sponsor GmbHUniversity, hospital or other
- Collaborators
- iOMEDICO AG, Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, GlaxoSmithKline
- Study start
- Oct 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Nov 2010 (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 the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.
Detailed description
The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive metastatic breast cancer. This study combines this therapy with the additional antimitotic mode of function by vinorelbine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine, Lapatinib, Vinorelbine | Experimental | Drug: Lapatinib and Capecitabine and Vinorelbine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Able to comply with the protocol
- ECOG performance status 0-1
- Adequate contraception
- Confirmed Her2/neu-positive, adenocarcinoma of the breast
Key exclusion criteria (14 listed)
- Pregnant or lactating women
- Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
- Asymptomatic with regards to tumor illness
- Previous treatment with lapatinib, capecitabine or vinorelbine
- Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
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 |
|---|---|---|
| Lapatinib and Capecitabine and VinorelbineAlso: Xeloda, Tyverb, NavirelDose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8 | Drug | Capecitabine, Lapatinib, Vinorelbine |
Primary outcome
Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
Time frame: 4 months
Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)
4 secondary outcomes
Overall response Rate
Time frame: 12 months
Progression free survival
Time frame: 12 months
Time to treatment failure (TTF)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: new methods of treatment, no more patients appilicable for study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Ulrike Soeling, MD principal investigator
Goethestr. 47, 34119 , Kassel, Germany
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lapatinib and Capecitabine and Vinorelbine in people with Metastatic Breast Cancer and HER2 Positive, run by Sponsor GmbH at 11 sites in Germany.
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 11 inclusion and 14 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 21 Nov 2014. 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 Germany. 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 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.
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: new methods of treatment, no more patients appilicable for study). 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?
Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine (time frame: 4 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 21 Nov 2014.