CancerPhase 2TOPO-LAPANCT00888810
Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
A Phase 2 study testing TOPOTECAN and LAPATINIB in people with Cancer and Ovarian, run by Centre Francois Baclesse at 21 sites in France.
Trial summary
The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- TOPOTECAN and LAPATINIB
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 39 participants
- Where
- 21 sitesFrance
- Study dates
- Mar 2008to not given
- 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
- Age superior or equal 18 years
- primitive ovarian adenocarcinoma histologically confirmed
- or peritoneal or fallopian tube adenocarcinoma histologically confirmed
- Progression or relapse within 12 months after the end of first line of platin based chemotherapy
- association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib).
- intra-peritoneal chemotherapy in first line is possible
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- No previous treatment with HER inhibitors (ex : gefitinib)
- HER status not necessary
- measurable lesions (RECIST criteria). and/or CA125 value higher than 2 fold the normal value or CA125 higher than 2 fold nadir value (if no normalized) proved by two samples distant of 1 month
- OMS inferior or equal 2.
- biological parameters as follow: creatininemia ≤ 150 µmol/L or clearance ≥ 50 mL/min,bilirubin ≤ 1,5 LNS,transaminases and or alcalin phosphatases ≤ 2 LNS without hepatic metastasis or ≤ 3 LNS if hepatic metastasis,neutrophils ≥ 1,5.109/L,plaquettes ≥ 100.109/L.
- normal FEV
- No previous treatment by chemotherapy, hormonotherapy, immunotherapy or radiotherapy within 4 weeks before inclusion
- No concomitant treatment forbidden with lapatinib.
- No previous treatment by Amiodarone in 6 months before inclusion
- signed informed consent
Who cannot join
- Previous treatment with :
- intensive chemotherapy with autograft
- two lignes of chemotherapy
- previous total abdominal irradiation
- previous chemotherapy with anti-HER treatment
- History of brain or meningitis metastasis uncontrolled.
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- Malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer.
- uncontrolled infectious pathology
- uncontrolled cardiovascular disease
- Patients with an active intestinal occlusion not permit oral treatment
- known hypersensibility to topotecan and its excipients
- Woman of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- Individual deprived of liberty
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Centre Paul Papin
Angers, 49933
CHU Jean MINJOZ
Besançon, 25030
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, CALVADOS, 14076
Centre G-F Leclerc
Dijon, 21076
CHD Les Oudairies
La Roche-sur-Yon, 85025
Centre Jean Bernard
Le Mans, 72015
Centre Val d'Aurelle
Montpellier, 34298
Centre azuréen de cancérologie
Mougins, 06250
Centre Alexis vautrin
Nancy, 54511
Centre Catherine de Sienne
Nantes, 44202
Centre René Gauducheau
Nantes, 44805
Centre Antoine Lacassagne
Nice, 06189
Hôpital Diaconesses
Paris, 75012
Institut CURIE
Paris, 75231
APHP Hopital TENON
Paris, 75970
Institut Jean Godinot
Reims, 51056
Institut de Cancérologie de la Loire
Saint-Etienne, 42271
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy
The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.
- Conditions
- Cancer, Ovarian, Relapse, Chemotherapy
- Being tested
- TOPOTECAN, LAPATINIB
- Keywords
- ovarian - cancer - relapse - topotecan - lapatinib
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPOTECANDrug
Also called HYCAMTIN
IV administration on Day 1, day 8 and day 15, at the dose level of 3.2 mg/m² for 6 cycles of 28 days(up to 8 cycles)
LAPATINIBDrug
Also called TYVERB
Daily oral administration during all the study. 1250 mg/day
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
Measured: every two cycles of chemotherapy
Secondary outcomes (1)
Global survival rate, survival rate without progression, response time, time without progression, safety, quality of life, Caracterisation of biological response (tumor, ascite and blood samples)
Measured: each cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMar 2008
Why it stopped: lack of efficacy (intermediate analysis)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Investigators
- Florence JOLY, MD-PHD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888810
- Sponsor's protocol ID
- 2007-005706-44
- Acronym
- TOPO-LAPA
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00888810
- Acronym / sponsor ID
- TOPO-LAPA / 2007-005706-44
- Conditions
- Cancer, Ovarian, Relapse, Chemotherapy
- Keywords
- ovarian - cancer - relapse - topotecan - lapatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy (intermediate analysis)
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Study start
- Mar 2008
- First posted
- 28 Apr 2009 (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 the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age superior or equal 18 years
- primitive ovarian adenocarcinoma histologically confirmed
- or peritoneal or fallopian tube adenocarcinoma histologically confirmed
- Progression or relapse within 12 months after the end of first line of platin based chemotherapy
- association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib).
Key exclusion criteria (13 listed)
- Previous treatment with :
- History of brain or meningitis metastasis uncontrolled.
- Malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer.
- uncontrolled infectious pathology
- uncontrolled cardiovascular disease
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 |
|---|---|---|
| TOPOTECANAlso: HYCAMTINIV administration on Day 1, day 8 and day 15, at the dose level of 3.2 mg/m² for 6 cycles of 28 days(up to 8 cycles) | Drug | – |
| LAPATINIBAlso: TYVERBDaily oral administration during all the study. 1250 mg/day | Drug | – |
Primary outcome
Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
Time frame: every two cycles of chemotherapy
1 secondary outcome
Global survival rate, survival rate without progression, response time, time without progression, safety, quality of life, Caracterisation of biological response (tumor, ascite and blood samples)
Time frame: each cycle of chemotherapy
Results and safety
The study was stopped early (reason given: lack of efficacy (intermediate analysis)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
- French National Protocol Registration SystemLink 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.
Florence JOLY, MD-PHD principal investigator
Centre François Baclesse
21 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 TOPOTECAN and LAPATINIB in people with Cancer and Ovarian, run by Centre Francois Baclesse at 21 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 16 inclusion and 13 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 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 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 efficacy (intermediate analysis)). 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?
Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. (time frame: every two cycles of chemotherapy). 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 28 Apr 2009.