Breast CancerPhase 1NCT00513058
Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer
A Phase 1 study testing Lapatinib and vinorelbine in people with Breast Cancer, run by UNICANCER at 5 sites in France.
Trial summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lapatinib 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
- 33 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2007to Apr 2012
- 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
- Female
- Menopausal status not specified
- Patients must have an estimated survival of at least 3 months
- WHO performance status (ECOG) 0-2
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1,500/mm³
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- Platelets ≥ 100,000/mm³
- Total bilirubin ≤ 2.5 mg/dL
- ALT and AST ≤ 3 times upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min
- LVEF ≥ 50% (echographic or isotopic method)
- Potentially reproductive patients must agree to use an effective contraceptive method while on study treatment
- Patients must be affiliated with a Social Security system
Who cannot join
- Uncontrolled cardiac pathology
- Dysphagia or inability to swallow the vinorelbine ditartrate soft capsules
- Malabsorption syndrome or disease significantly affecting gastrointestinal function
- Preexisting neuropathy (grade ≥ 2)
- Pregnant women, women who are likely to become pregnant, or women who are breastfeeding
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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- Individuals deprived of liberty
- Prior major resection of stomach or proximal bowel that could affect absorption of oral drugs
- Prior vinorelbine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Institut Curie Hopital
Paris, 75248
Centre Rene Huguenin
Saint-Cloud, 92211
Institut Claudius Regaud
Toulouse, 31052
About this study
Official title: Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the tolerability and feasibility of the lapatinib ditosylate and vinorelbine ditartrate combination by determining the maximum tolerated dose of vinorelbine ditartrate in combination with a biologically active dose of lapatinib ditosylate.
Secondary
- Determine the maximum administered dose.
- Investigate the pharmacokinetic interactions related to the combination of vinorelbine ditartrate and lapatinib ditosylate.
- Determine the toxicity of vinorelbine ditartrate and lapatinib ditosylate.
- Determine the objective response rate in patients with measurable lesions.
- Validate the safety and efficacy of the oral vinorelbine ditartrate and lapatinib ditosylate combination, according to the vinorelbine ditartrate oral/IV dose equivalence.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral lapatinib ditosylate on days -7 to 21 for course 1 and on days 1-21 for all other courses. Patients also receive vinorelbine ditartrate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-9 patients receive escalating doses of lapatinib ditosylate and vinorelbine ditartrate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity during course 1.
Once the MTD is determined for oral lapatinib ditosylate and IV vinorelbine ditartrate, an additional cohort of 9 patients receive oral vinorelbine ditartrate with oral lapatinib ditosylate as above.
- Conditions
- Breast Cancer
- Being tested
- Lapatinib, vinorelbine
- Keywords
- metastatic breast cancer, advanced 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.
LapatinibDrug
Also called TYVERB
Dose level (DL) 1 : 750 mg/d DL2, DL3, DL4: 1000 mg/d DL5, DL7, DL8: 1250 mg/d DL6: 1500 mg/d
vinorelbineDrug
Also called NAVELBINE
DL1, DL2: 20 mg/m2 DL3: 22.5 mg/m2 DL4, DL5, DL6: 25 mg/m2 DL7: 27.5 mg/m2 DL8: 30 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| lapatinib + vinorelbine | Experimental | * starting with loading dose of lapatinib per os for 7 days
* then, combining lapatinib (oral daily continuous) + vinorelbine (intravenous, day 1 and 8 every 3 weeks) Receives: Drug: Lapatinib; Drug: vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as assessed by NCI CTCAE v3.0
Measured: during the first cycle of treatment
Secondary outcomes (2)
Pharmacokinetic interactions between vinorelbine ditartrate (oral or IV) and lapatinib ditosylate
Measured: during the first cycle of treatment
Tumor response as assessed by RECIST criteria after every 2 courses
Measured: during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionApr 2012
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 UNICANCERThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Fumoleau, MD, PhD, Study chair, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513058
- Sponsor's protocol ID
- CDR0000558406
- Other IDs
- FRE-FNCLCC-GEP-01/0506, 2005-005167-28, 2005
- Status last verified
- Jan 2014
- First submitted
- 6 Aug 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2
- ClinicalTrials.gov ID
- NCT00513058
- Acronym / sponsor ID
- CDR0000558406
- Conditions
- Breast Cancer
- Keywords
- metastatic breast cancer, advanced breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Aug 2007 (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: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the tolerability and feasibility of the lapatinib ditosylate and vinorelbine ditartrate combination by determining the maximum tolerated dose of vinorelbine ditartrate in combination with a biologically active dose of lapatinib ditosylate.
Secondary
- Determine the maximum administered dose.
- Investigate the pharmacokinetic interactions related to the combination of vinorelbine ditartrate and lapatinib ditosylate.
- Determine the toxicity of vinorelbine ditartrate and lapatinib ditosylate.
- Determine the objective response rate in patients with measurable lesions.
- Validate the safety and efficacy of the oral vinorelbine ditartrate and lapatinib ditosylate combination, according to the vinorelbine ditartrate oral/IV dose equivalence.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral lapatinib ditosylate on days -7 to 21 for course 1 and on days 1-21 for all other courses. Patients also receive vinorelbine ditartrate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-9 patients receive escalating doses of lapatinib ditosylate and vinorelbine ditartrate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity during course 1.
Once the MTD is determined for oral lapatinib ditosylate and IV vinorelbine ditartrate, an additional cohort of 9 patients receive oral vinorelbine ditartrate with oral lapatinib ditosylate as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lapatinib + vinorelbine | Experimental | Drug: Lapatinib, Drug: vinorelbine* starting with loading dose of lapatinib per os for 7 days * then, combining lapatinib (oral daily continuous) + vinorelbine (intravenous, day 1 and 8 every 3 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female
- Menopausal status not specified
- Patients must have an estimated survival of at least 3 months
- WHO performance status (ECOG) 0-2
- Hemoglobin ≥ 9 g/dL
Key exclusion criteria (9 listed)
- Uncontrolled cardiac pathology
- Dysphagia or inability to swallow the vinorelbine ditartrate soft capsules
- Malabsorption syndrome or disease significantly affecting gastrointestinal function
- Preexisting neuropathy (grade ≥ 2)
- Pregnant women, women who are likely to become pregnant, or women who are breastfeeding
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 |
|---|---|---|
| LapatinibAlso: TYVERBDose level (DL) 1 : 750 mg/d DL2, DL3, DL4: 1000 mg/d DL5, DL7, DL8: 1250 mg/d DL6: 1500 mg/d | Drug | lapatinib + vinorelbine |
| vinorelbineAlso: NAVELBINEDL1, DL2: 20 mg/m2 DL3: 22.5 mg/m2 DL4, DL5, DL6: 25 mg/m2 DL7: 27.5 mg/m2 DL8: 30 mg/m2 | Drug | lapatinib + vinorelbine |
Primary outcome
Toxicity as assessed by NCI CTCAE v3.0
Time frame: during the first cycle of treatment
2 secondary outcomes
Pharmacokinetic interactions between vinorelbine ditartrate (oral or IV) and lapatinib ditosylate
Time frame: during the first cycle of treatment
Tumor response as assessed by RECIST criteria after every 2 courses
Time frame: during 6 months
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 Jan 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.
Pierre Fumoleau, MD, PhD study chair
Centre Georges Francois Leclerc
5 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 vinorelbine in people with Breast Cancer, run by UNICANCER at 5 sites in France.
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 13 inclusion and 9 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 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?
Toxicity as assessed by NCI CTCAE v3.0 (time frame: during the first cycle of treatment). 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 Jan 2014.