Metastatic Breast CancerPhase 1/2LapDocNCT01044485
Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
A Phase 1/2 study testing lapatinib and docetaxel in people with Metastatic Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
The objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. 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?
- lapatinib and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Nov 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over or equal 18 years·
- ECOG Performance Status of 0 to 2·
- Patients with histological or cytological confirmed breast cancer, HER positive (IHC 3+, or IHC 2+ and FISH/CISH +, or FISH+ or CISH+ only), not amenable for an alternative curative strategy in first line metastatic setting·
- Patients who receive hormonotherapy for metastatic disease or who received chemotherapy in adjuvant setting if recurrence occur after 6 months are eligible·
- Patient must have not received the last injection of trastuzumab within the six weeks·
- Subjects must have completed prior radiotherapy treatment at least 4 weeks from enrolment and recovered from all treatment-related toxicities· Subjects must have tissue available to prospectively determine treatment assignment and to compare tumor response with intra-tumor expression levels of relevant biomarkers·
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- No prior systemic investigational agent within the past 30 days or topical investigational drugs within the past 7 days·
- Subjects must have a cardiac ejection fraction within the institutional range of normal as measured by ECHO (echocardiogram) or MUGA (Multigated Acquisition) scan·
- Subjects must have adequate haematological, hepatic, and renal function·
- Affiliation to a social insurance program is required
Who cannot join
- Subjects with elevations of transaminase (ALT and/or AST) greater than 2.5 times the upper limit of the normal range (ULN) are NOT eligible for the study·
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier·
- Patients who have had prior treatment with EGFR targeting therapies· All herbal (alternative) medicines are excluded·
- Patients with known brain metastases·
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.·
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, peripheral neuropathy of grade 2 or greater, or psychiatric illness/social situations that would limit compliance with study requirements·
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- Pregnant women are excluded from this study because lapatinib is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects·
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib·
- Patients with gastro intestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)· Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)· Previous allergic reaction to docetaxel and/or polyascorbate· Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors·
- Active cardiac disease, defined as: history of uncontrolled or symptomatic angina pectoris, history of cardiac arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Georges François Leclerc
Dijon, Bourgogne-Franche-Comté, 21000
About this study
Official title: A Multicenter Open-label, Phase I/II Dose Escalation Study of Oral Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
The objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. It is proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with docetaxel 75 mg/m² without systematic support of growth factors, starting after the completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate efficacy of lapatinib in combination with docetaxel.
Read the detailed description
Docetaxel is a major drug in the treatment of metastatic breast cancer. In HER2 negative tumor, the first line treatment is based on docetaxel containing regimen: docetaxel alone, docetaxel + anthracycline or docetaxel + capecitabine. The efficacy of docetaxel in combination with trastuzumab has been demonstrated in first line metastatic breast cancer overexpressing erbB2 receptor. The response rate (RR) and the time to progression (TTP) observed were even higher than those obtained with paclitaxel +trastuzumab. Docetaxel is more and more used in first line metastatic setting, becoming the first Taxane used in this setting.As trastuzumab may raise safety/tolerability concerns, and as its interest in trastuzumab refractory patients may be limited, there is a need to find new drugs to combine with docetaxel in breast cancer, and to address the specific interaction/safety profile of this combination.The association of lapatinib and docetaxel will be the key combination in metastatic breast cancer development for GSK.The conclusion of a phase I trial EGF 10021 trial conducted in the US which assessed the combination of lapatinib and docetaxel showed that the acceptable optimal tolerated regimen (OTR) of docetaxel (75 mg/m²) was obtained in combination with lapatinib 1250 mg with systematic growth factor support.Data from an ongoing EGF100161 phase I study evaluating the OTR of lapatinib + docetaxel + trastuzumab shows that the association of lapatinib 1250 mg with docetaxel 75mg/m² is haematological toxic and has recently been amended to evaluate lapatinib 1250 mg with docetaxel 75 mg/m² with systematic growth factor support.A phase I/II EORTC study evaluating docetaxel plus lapatinib in neoadjuvant breast cancer patients has just started. The phase I part of this study will evaluate several lapatinib and docetaxel dose levels before conducting phase II.
The phase I part will enrol patients (in cohorts of 3 or 6) to determine in a step-wise approach, the OTR of lapatinib and docetaxel. Patients should not be entered at a higher dose level until all patients in the previous cohort complete the first cycle of treatment, this first cycle is used to determine OTR. Dose modification of lapatinib will be based on any observed toxicity in the treatment period. The OTR will be defined as the dose level at which £ 1 of 6 patients experiences the DLT (dose limiting toxicity).If no DLT is observed in the first 3 patients at a particular dose level during the first cycle (3 week treatment period), recruitment will start at the next dose levelIf 1/3 patients experiences a DLT at a particular dose level, additional 3 patients will be enrolled at that dose level to a total of 6 patients if no DLT occurred againIf 1/6 patients experiences a DLT at a particular dose level, recruitment will start at the next dose levelIf ³ 2/6 patients experiences the same DLT at a particular dose level, the dose level is not considered to be tolerableIf ³ 2/6 patients experiences two distinct DLT at a particular dose level, additional 3 patients will be enrolled at that dose level to a total of 9 patients. If one of the previously described DLT occurred again among the new enrolled patients, the dose level is not considered to be tolerableA total of 12 patients will be treated at the OTR.The OTR is defined as the dose level at which no more than 1 of 6 patients experiences a DLT.The DLT for this study is defined during cycle 1 for the dose escalation step as:· any grade 3-4 non hematological toxicity as defined by the Common Toxicity Criteria, version 3 (with the exclusion of alopecia, nausea, vomiting, diarrhea, infusion related that can be rapidly controlled with appropriate measures)· an absolute neutrophil count (ANC) < 0.5x109 /L lasting for > = 7 day· febrile neutropenia defined as ANC < 1.0 x109 /L and fever at least 38.5°C· thrombocytopenia < 25, 000/µl or thrombocytopenic bleeding requiring transfusion· grade 3 or higher left ventricular cardiac dysfunction or a ≥ 20% decrease from baseline in left ventricular ejection fraction (LVEF) that is also below the institution's lower limit of normal (LLN), and confirmed by a repeat evaluation 1 to 2 weeks following the first evaluation.
- Conditions
- Metastatic Breast Cancer
- Being tested
- lapatinib, docetaxel
- Keywords
- HER-2 positive advanced or metastatic breast cancer, dose escalation study, lapatinib, docetaxel
- 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
escalation dose from 1250 to 1500 mg in association with docetaxel
docetaxelDrug
escalation dose from 75 mg/m2 to 100 mg/m2 in association with lapatinib
| Study group | Role | What they receive |
|---|---|---|
| lapatinib + docetaxel | Other | dose level Lapatinib (OD) Docetaxel (q3wks) Systematic Growth factor Minus 0 1250 mg 75 mg/m2 + systematic growth factor support
0, 1250mg 75 mg/m2 No
+1 1500mg 75mg/m2 No
Minus +1* 1500mg 75mg/m2 + systematic growth factor support
+2 1250mg 100mg/m2 No
Minus +2* + systematic growth factor support
+3 1500mg 100mg/m2 No
Minus +3* + systematic growth factor support
Apart within the minus dose levels, G-CSF support should be added only as rescue strategy if severe neutropenia occurred during the first cycle of studied dose.Patients will receive 4 cycles of the association. In case of benefit of the treatment, they should continue the treatment with lapatinib until progression.* patients will be included at level "minus X" only if 2 DLT out of 6 patients based on febrile neutropenia occurred at level "X" Receives: Drug: lapatinib; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the optimal tolerated regimen of lapatinib administered in combination with docetaxel as first-line therapy in patients with metastatic breast cancer
Measured: during first cycle ( each cycle last 3 weeks)
Secondary outcomes (7)
To evaluate the dose-limiting toxicity
Measured: each weeks of each cycle and after the end of the study
To evaluate anti-tumour activity in terms of response
Measured: each cycle and at the end of the study
To evaluate anti-tumour activity in time to response
Measured: each cycle and at the end of the study
To evaluate anti-tumour activity in terms of response duration
Measured: each cycle and at the end of the study
To evaluate anti-tumour activity, in terms time to progression (TTP)
Measured: each cycle and at the end of the study
To evaluate anti-tumour activity, in terms of time to treatment failure (TTF)
Measured: each cycle and at the end of the study
To evaluate anti-tumour activity, in terms of overall survival (OS)
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startNov 2008
- Primary completionNov 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Sanofi
- Responsible party
- Sponsor
- Investigators
- Nicolas Isambert, MD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044485
- Sponsor's protocol ID
- 0205-1isni 07 / 001.112
- Acronym
- LapDoc
- Status last verified
- Sep 2012
- First submitted
- 5 Jan 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label, Phase I/II Dose Escalation Study of Oral Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01044485
- Acronym / sponsor ID
- LapDoc / 0205-1isni 07 / 001.112
- Conditions
- Metastatic Breast Cancer
- Keywords
- HER-2 positive advanced or metastatic breast cancer, dose escalation study, lapatinib, docetaxel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Sanofi
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (actual)
- First posted
- 8 Jan 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 objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. It is proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with docetaxel 75 mg/m² without systematic support of growth factors, starting after the completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate efficacy of lapatinib in combination with docetaxel.
Detailed description
Docetaxel is a major drug in the treatment of metastatic breast cancer. In HER2 negative tumor, the first line treatment is based on docetaxel containing regimen: docetaxel alone, docetaxel + anthracycline or docetaxel + capecitabine. The efficacy of docetaxel in combination with trastuzumab has been demonstrated in first line metastatic breast cancer overexpressing erbB2 receptor. The response rate (RR) and the time to progression (TTP) observed were even higher than those obtained with paclitaxel +trastuzumab. Docetaxel is more and more used in first line metastatic setting, becoming the first Taxane used in this setting.As trastuzumab may raise safety/tolerability concerns, and as its interest in trastuzumab refractory patients may be limited, there is a need to find new drugs to combine with docetaxel in breast cancer, and to address the specific interaction/safety profile of this combination.The association of lapatinib and docetaxel will be the key combination in metastatic breast cancer development for GSK.The conclusion of a phase I trial EGF 10021 trial conducted in the US which assessed the combination of lapatinib and docetaxel showed that the acceptable optimal tolerated regimen (OTR) of docetaxel (75 mg/m²) was obtained in combination with lapatinib 1250 mg with systematic growth factor support.Data from an ongoing EGF100161 phase I study evaluating the OTR of lapatinib + docetaxel + trastuzumab shows that the association of lapatinib 1250 mg with docetaxel 75mg/m² is haematological toxic and has recently been amended to evaluate lapatinib 1250 mg with docetaxel 75 mg/m² with systematic growth factor support.A phase I/II EORTC study evaluating docetaxel plus lapatinib in neoadjuvant breast cancer patients has just started. The phase I part of this study will evaluate several lapatinib and docetaxel dose levels before conducting phase II.
The phase I part will enrol patients (in cohorts of 3 or 6) to determine in a step-wise approach, the OTR of lapatinib and docetaxel. Patients should not be entered at a higher dose level until all patients in the previous cohort complete the first cycle of treatment, this first cycle is used to determine OTR. Dose modification of lapatinib will be based on any observed toxicity in the treatment period. The OTR will be defined as the dose level at which £ 1 of 6 patients experiences the DLT (dose limiting toxicity).If no DLT is observed in the first 3 patients at a particular dose level during the first cycle (3 week treatment period), recruitment will start at the next dose levelIf 1/3 patients experiences a DLT at a particular dose level, additional 3 patients will be enrolled at that dose level to a total of 6 patients if no DLT occurred againIf 1/6 patients experiences a DLT at a particular dose level, recruitment will start at the next dose levelIf ³ 2/6 patients experiences the same DLT at a particular dose level, the dose level is not considered to be tolerableIf ³ 2/6 patients experiences two distinct DLT at a particular dose level, additional 3 patients will be enrolled at that dose level to a total of 9 patients. If one of the previously described DLT occurred again among the new enrolled patients, the dose level is not considered to be tolerableA total of 12 patients will be treated at the OTR.The OTR is defined as the dose level at which no more than 1 of 6 patients experiences a DLT.The DLT for this study is defined during cycle 1 for the dose escalation step as:· any grade 3-4 non hematological toxicity as defined by the Common Toxicity Criteria, version 3 (with the exclusion of alopecia, nausea, vomiting, diarrhea, infusion related that can be rapidly controlled with appropriate measures)· an absolute neutrophil count (ANC) < 0.5x109 /L lasting for > = 7 day· febrile neutropenia defined as ANC < 1.0 x109 /L and fever at least 38.5°C· thrombocytopenia < 25, 000/µl or thrombocytopenic bleeding requiring transfusion· grade 3 or higher left ventricular cardiac dysfunction or a ≥ 20% decrease from baseline in left ventricular ejection fraction (LVEF) that is also below the institution's lower limit of normal (LLN), and confirmed by a repeat evaluation 1 to 2 weeks following the first evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lapatinib + docetaxel | Other | Drug: lapatinib, Drug: docetaxeldose level Lapatinib (OD) Docetaxel (q3wks) Systematic Growth factor Minus 0 1250 mg 75 mg/m2 + systematic growth factor support 0, 1250mg 75 mg/m2 No +1 1500mg 75mg/m2 No Minus +1* 1500mg 75mg/m2 + systematic growth factor support +2 1250mg 100mg/m2 No Minus +2* + systematic growth factor support +3 1500mg 100mg/m2 No Minus +3* + systematic growth factor support Apart within the minus dose levels, G-CSF support should be added only as rescue strategy if severe neutropenia occurred during the first cycle of studied dose.Patients will receive 4 cycles of the association. In case of benefit of the treatment, they should continue the treatment with lapatinib until progression.* patients will be included at level "minus X" only if 2 DLT out of 6 patients based on febrile neutropenia occurred at level "X" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age over or equal 18 years·
- ECOG Performance Status of 0 to 2·
- Patients with histological or cytological confirmed breast cancer, HER positive (IHC 3+, or IHC 2+ and FISH/CISH +, or FISH+ or CISH+ only), not amenable for an alternative curative strategy in first line metastatic setting·
- Patients who receive hormonotherapy for metastatic disease or who received chemotherapy in adjuvant setting if recurrence occur after 6 months are eligible·
- Patient must have not received the last injection of trastuzumab within the six weeks·
Key exclusion criteria (10 listed)
- Subjects with elevations of transaminase (ALT and/or AST) greater than 2.5 times the upper limit of the normal range (ULN) are NOT eligible for the study·
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier·
- Patients who have had prior treatment with EGFR targeting therapies· All herbal (alternative) medicines are excluded·
- Patients with known brain metastases·
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.·
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 |
|---|---|---|
| lapatinibescalation dose from 1250 to 1500 mg in association with docetaxel | Drug | lapatinib + docetaxel |
| docetaxelescalation dose from 75 mg/m2 to 100 mg/m2 in association with lapatinib | Drug | lapatinib + docetaxel |
Primary outcome
To determine the optimal tolerated regimen of lapatinib administered in combination with docetaxel as first-line therapy in patients with metastatic breast cancer
Time frame: during first cycle ( each cycle last 3 weeks)
7 secondary outcomes
To evaluate the dose-limiting toxicity
Time frame: each weeks of each cycle and after the end of the study
To evaluate anti-tumour activity in terms of response
Time frame: each cycle and at the end of the study
To evaluate anti-tumour activity in time to response
Time frame: each cycle and at the end of the study
To evaluate anti-tumour activity in terms of response duration
Time frame: each cycle and at the end of the study
To evaluate anti-tumour activity, in terms time to progression (TTP)
Time frame: each cycle and at the end of the study
To evaluate anti-tumour activity, in terms of time to treatment failure (TTF)
Time frame: each cycle and at the end of the study
To evaluate anti-tumour activity, in terms of overall survival (OS)
Time frame: at the end of the study
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 25 Sep 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.
Nicolas Isambert, MD principal investigator
Centre Georges François Leclerc
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 lapatinib and docetaxel in people with Metastatic Breast Cancer, run by Centre Georges Francois Leclerc at 1 site 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 10 inclusion and 10 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 25 Sep 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 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 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?
To determine the optimal tolerated regimen of lapatinib administered in combination with docetaxel as first-line therapy in patients with metastatic breast cancer (time frame: during first cycle ( each cycle last 3 weeks)). 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 25 Sep 2012.