Lung CancerPhase 2GFPC 07-01NCT00744900
Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Pemetrexed, cisplatin in people with Lung Cancer, run by University Hospital, Brest at 25 sites in France.
Trial summary
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pemetrexed, cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 25 sitesFrance
- Study dates
- Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cytologically or histologically confirmed NSCLC.
- Patient with brain metastasis not amenable to surgery or radiosurgery with curative intent
- At least one brain measurable lesion using RECIST criteria
- ECOG Performance Status ≤2
- No prior chemotherapy for this cancer
- Prior surgery is allowed provided there is a relapse or progression after the procedure.
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- Adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil count (ANC) superior or equal to 1.5 X109/L, platelets superior or equal to 100 X 109/L, and hemoglobin superior or equal to 9 g/dL; Hepatic: bilirubin <1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <3xULN (or <5xULN with liver metastases); Renal: Calculated creatinine clearance (CrCl) superior or equal to 45mL/min based on the standard Cockroft and Gault formula
- Signed informed consent document from the patient
- Patient must be at least 18 years of age.
- Estimated life expectancy of at least 12 weeks.
- Effective contraception (men and women) for and during the 6 months following the end of treatment
Who cannot join
- Symptomatic brain metastasis
- Have received prior radiotherapy for brain metastasis
- Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
- A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete study.
- Inability to discontinue administration of aspirin at a dose >1.3g/day or other non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam).
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- Presence of fluid accumulations in third spaces, e.g., ascite or pleural effusion, which can be detected clinically (during physical examination), and which cannot be adequately controlled by drainage or other procedures prior to inclusion in the study.
- Peripheral neuropathy > CTC Grade 2
- Patient compliance or geographic distance precluding adequate follow up.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Centre Hôspitalier du Pays d'Aix, Service des Maladies Respiratoires
Aix-en-Provence, 13616
CHU d'Angers, Service de Pneumologie
Angers, 49033
Médecine 4, C.H.G. de la Fontonne Antibes
Antibes, 06606
CHU brest, institut de cancérologie et d'hématologie
Brest, 29200
Centre François Baclesse
Caen, 14000
Centre Hospitalier René Dubos - Pontoise, Service d'Oncologie - Hématologie Clinique
Cergy-Pontoise, 95303
Centre Hospitalier, Service de Pneumologie
Charleville, 08 000
CHI, Service de Pneumologie
Créteil, 94010
Pneumologie, Centre hôspitalier, DRAGUIGNAN
Draguignan, 83300
CH GAP
Gap, 05000
Centre Hospitalier Départemental, Service de Pneumologie,
La Roche-sur-Yon, 85000
Hôpital A. Mignot, Service de Pneumologie
Le Chesnay, 78157
Hopital de la Croix Rousse
Lyon, 69317
Centre Hôspitalier, Service de Pneumo-Neuro
Mantes-la-Jolie, 78200
Hôpital Sainte Margueritte
Marseille, 13274
Serv. de Pneumo-Allergo, CH de Martigues
Martigues, 13695
Serv. de Pneumo - Hôpital St Antoine
Paris, 75571
Service Pneumologie, Pavillon 1A, CH de Lyon-Sud
Pierre-Bénite, 69495
Hôpital Pontchailloux, Service de Pneumologie.
Rennes, 35033
CHG, Service de Pneumologie
Roanne, 42300
Luc THIBERVILLE
Rouen, 76031
CHU de ROUEN, Hôpital Bois Guillaume, Serv. de Pneumo.
Rouen, 76233
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
CHU, Service du Pr. Carles
Toulouse, 31059
Pneumologie, Centre Hospitalier
Villefranche-sur-Saône, 69655
About this study
Official title: A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile.
The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.
The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.
- Conditions
- Lung Cancer
- Being tested
- Pemetrexed, cisplatin
- Keywords
- Pemetrexed, Non-Small Cell Lung Cancer, brain metastasis
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed, cisplatinDrug
Alimta 500mg/m² IV 10 min infusion and Cisplatin 75mg/m² IV 60 min on day 1. Cycle will be repeated each 21 days.Folic acid orally 400µg should begin 5-7days prior to the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. Vitamin B12 will be administered as a 1000 mg intramuscular injection, approximately one week before Day 1 of cycle 1 and should repeat approximately every 9 weeks Dexamethasone, 4 mg or equivalent, should be taken orally twice per day on the day before, the day of, and the day after each dose of pemetrexed.WBRT will be administered with high energy photons systematically after cycle 6 or in case of stable disease (SD) after cycle 4 or progressive disease (PD) at any time. The dose will be 3Gy by fraction, 1 fraction per day, for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Pemetrexed, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective of this study is overall response rate on brain metastasis according to RECIST criteria.
Measured: After cycles 2, 4 and 6 and every 6 weeks after study drug completion in absence of disease progression.
Secondary outcomes (1)
Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms and overall survival.
Measured: After cycles 2, 4 and 6 and every 6 weeks after study drug completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Investigators
- Gilles Robinet, MD, Principal investigator, CHU BrestBarlesi Barlesi, MD, Ph.D, Principal investigator, Assistance Publique Hôpitaux de MarseilleIsabelle Monet, MD, Principal investigator, Centre Hospitalier, Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744900
- Sponsor's protocol ID
- GFPC 07-01
- Other IDs
- RB 07.103
- Acronym
- GFPC 07-01
- Status last verified
- Jul 2009
- First submitted
- 29 Aug 2008
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).
- ClinicalTrials.gov ID
- NCT00744900
- Acronym / sponsor ID
- GFPC 07-01 / GFPC 07-01
- Conditions
- Lung Cancer
- Keywords
- Pemetrexed, Non-Small Cell Lung Cancer, brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Sep 2008
- First posted
- 1 Sep 2008 (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.
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile.
The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.
The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Pemetrexed, cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with cytologically or histologically confirmed NSCLC.
- Patient with brain metastasis not amenable to surgery or radiosurgery with curative intent
- At least one brain measurable lesion using RECIST criteria
- ECOG Performance Status ≤2
- No prior chemotherapy for this cancer
Key exclusion criteria (9 listed)
- Symptomatic brain metastasis
- Have received prior radiotherapy for brain metastasis
- Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
- A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete study.
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 |
|---|---|---|
| Pemetrexed, cisplatinAlimta 500mg/m² IV 10 min infusion and Cisplatin 75mg/m² IV 60 min on day 1. Cycle will be repeated each 21 days.Folic acid orally 400µg should begin 5-7days prior to the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. Vitamin B12 will be administered as a 1000 mg intramuscular injection, approximately one week before Day 1 of cycle 1 and should repeat approximately every 9 weeks Dexamethasone, 4 mg or equivalent, should be taken orally twice per day on the day before, the day of, and the day after each dose of pemetrexed.WBRT will be administered with high energy photons systematically after cycle 6 or in case of stable disease (SD) after cycle 4 or progressive disease (PD) at any time. The dose will be 3Gy by fraction, 1 fraction per day, for 10 days. | Drug | A |
Primary outcome
Objective of this study is overall response rate on brain metastasis according to RECIST criteria.
Time frame: After cycles 2, 4 and 6 and every 6 weeks after study drug completion in absence of disease progression.
1 secondary outcome
Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms and overall survival.
Time frame: After cycles 2, 4 and 6 and every 6 weeks after study drug completion.
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 28 Jul 2009.
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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.
Gilles Robinet, MD principal investigator
CHU Brest
Barlesi Barlesi, MD, Ph.D principal investigator
Assistance Publique Hôpitaux de Marseille
Isabelle Monet, MD principal investigator
Centre Hospitalier, Créteil
25 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 Pemetrexed, cisplatin in people with Lung Cancer, run by University Hospital, Brest at 25 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 11 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 28 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 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?
Objective of this study is overall response rate on brain metastasis according to RECIST criteria. (time frame: After cycles 2, 4 and 6 and every 6 weeks after study drug completion in absence of disease progression.). 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 Jul 2009.