Cancer of StomachPhase 2FOXAGASTNCT02486601
NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma
A Phase 2 study testing nab-paclitaxel and FOLFOX in people with Cancer of Stomach, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 7 sites in France.
Trial summary
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Stomach
- What is being tested?
- nab-paclitaxel and FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2015to Jun 2022
- 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
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically or cytologically proven adenocarcinoma of the low oesophagus or of the stomach, (from 1/3 inferior of the oesophagus to pylorus)
- HER2 negative tumors
- Localized and operable disease confirmed (stage I-III),
- No prior therapy for localized disease ,
- Age ≥18 years,
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- Performance status (PS) 0-2,
- Haematological status: neutrophils (ANC) > 2.0x109/L; platelets >100x109/L; haemoglobin ≥9g/dL,
- Adequate renal function: serum creatinine level <150µM and creatinine clearance test > 30mL/min,
- Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (Upper Limit of Normal)
- Total bilirubin ≤1.5 x ULN,
- Albumin ≥25g/L
- Baseline evaluations performed before inclusion: clinical and blood evaluations no more than 2 weeks (14 days) prior to inclusion, tumor assessment (CT-scan, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to inclusion,
- Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least six months after the end of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 72 hours days prior to starting nab-paclitaxel neo-adjuvant and adjuvant treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment,
- Registration in a national health care system (CMU included for France).
Who cannot join
- Metastatic disease (stage IV)
- Non operable primary tumor
- Patient using warfarin,
- Uncontrolled hypercalcemia (corrected serum calcium > 2.55 mmol/l),
- Pre-existing permanent neuropathy (NCI grade ≥2),
- Known dihydropyrimidine dehydrogenase (DPD) deficiency,
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- Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- Treatment with any other investigational medicinal product within 28 days prior to study entry,
- Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months),
- Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C.
- Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- Patients with known allergy to any excipient of study drugs,
- Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin
- Patient with any medical or psychological condition, deemed by the investigator to likely interfere with patient's ability to sign informed consent or cooperate and participate in the study, including tutelage or guardianship.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030
33-3-8166-8393
Stéphano KIM
- Recruiting
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94000
33-1-4981-2579
Christophe TOURNIGAND
- Recruiting
Centre Léon Bérard
Lyon
E
Christelle de la FOUCHARDIERE
- Recruiting
Hôpital Privé Jean Mermoz
Lyon
Gérard LLEDO
- Recruiting
CHU Pitie-Salpetriere
Paris, 75651
33-1-42-16-00-00
Jean-Baptiste BACHET
- Recruiting
Hopital Saint Antoine
Paris
Thierry ANDRE
- Recruiting
Institut Mutualiste Montsouris
Paris
Christophe, PhD
Christophe LOUVET, PhD
About this study
Official title: Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.
In neoadjuvant setting : 3 months of treatment
Read more
Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.
Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the result of the neo-adjuvant treatment and the ability of patients to receive adjuvant chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks post-operatively.
Read the detailed description
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.
In neoadjuvant setting : 3 months of treatment
Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.
- Conditions
- Cancer of Stomach
- Being tested
- nab-paclitaxel, FOLFOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called ABRAXANE
nab-paclitaxel : 150 mg/m2 D1 every 2 weeks
FOLFOXDrug
Leucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks Fluorouracil (5-FU) infusion: 2400mg/m2 48h infusion every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel + FOLFOX | Experimental | nab-paclitaxel + FOLFOX nab-paclitaxel: 150 mg/m2 D1 every 2 weeks Leucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks 5-FU infusion: 2400mg/m2 48h infusion every 2 weeks 6 pre-operative cycles 6 post-operative cycles (optional) Receives: Drug: nab-paclitaxel; Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pathological response rate
Measured: after three months of neoadjuvant chemotherapy
Secondary outcomes (6)
Disease Free Survival (DFS)
Measured: time from the date of inclusion up to the date of disease progression or death whichever occurs last up to 7 years
Overall Survival (OS)
Measured: time interval form the inclusion to the date of the death from any cause up to 7 years
Health related to Quality of Life (QoL)
Measured: up to 8 months
Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events
Measured: time from randomisation up to end of study up to 7 years
Assessment of biomarkers when appropriate
such as SPARC, TS, DPD, ERCC1
Measured: 1 day of biopsie from diagnosis, and tumor from surgery
Assessment of genetic polymorphism involved in tumor-response when appropriate
CYP2A6, TS, DPD, ERCC1, ERCC2
Measured: 28 days after last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2017
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of StomachStudies 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Christophe LOUVET, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486601
- Sponsor's protocol ID
- FOXAGAST -D14-1
- Acronym
- FOXAGAST
- Status last verified
- Feb 2019
- First submitted
- 12 Jun 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02486601
- Acronym / sponsor ID
- FOXAGAST / FOXAGAST -D14-1
- Conditions
- Cancer of Stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jun 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 1 Jul 2015 (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.
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.
In neoadjuvant setting : 3 months of treatment
Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.
Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the result of the neo-adjuvant treatment and the ability of patients to receive adjuvant chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks post-operatively.
Detailed description
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.
In neoadjuvant setting : 3 months of treatment
Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel + FOLFOX | Experimental | Drug: nab-paclitaxel, Drug: FOLFOXnab-paclitaxel + FOLFOX nab-paclitaxel: 150 mg/m2 D1 every 2 weeks Leucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks 5-FU infusion: 2400mg/m2 48h infusion every 2 weeks 6 pre-operative cycles 6 post-operative cycles (optional) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically or cytologically proven adenocarcinoma of the low oesophagus or of the stomach, (from 1/3 inferior of the oesophagus to pylorus)
- HER2 negative tumors
- Localized and operable disease confirmed (stage I-III),
- No prior therapy for localized disease ,
Key exclusion criteria (14 listed)
- Metastatic disease (stage IV)
- Non operable primary tumor
- Patient using warfarin,
- Uncontrolled hypercalcemia (corrected serum calcium > 2.55 mmol/l),
- Pre-existing permanent neuropathy (NCI grade ≥2),
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 |
|---|---|---|
| nab-paclitaxelAlso: ABRAXANEnab-paclitaxel : 150 mg/m2 D1 every 2 weeks | Drug | nab-paclitaxel + FOLFOX |
| FOLFOXLeucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks Fluorouracil (5-FU) infusion: 2400mg/m2 48h infusion every 2 weeks | Drug | nab-paclitaxel + FOLFOX |
Primary outcome
Complete pathological response rate
Time frame: after three months of neoadjuvant chemotherapy
6 secondary outcomes
Disease Free Survival (DFS)
Time frame: time from the date of inclusion up to the date of disease progression or death whichever occurs last up to 7 years
Overall Survival (OS)
Time frame: time interval form the inclusion to the date of the death from any cause up to 7 years
Health related to Quality of Life (QoL)
Time frame: up to 8 months
Safety profile of the combination of nab-paclitaxel + FOLFOX regimen assessed by adverse events
Time frame: time from randomisation up to end of study up to 7 years
Assessment of biomarkers when appropriate
Time frame: 1 day of biopsie from diagnosis, and tumor from surgery
Assessment of genetic polymorphism involved in tumor-response when appropriate
Time frame: 28 days after last study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
Christophe LOUVET principal investigator
Institut Mutualiste Montsouris
7 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 nab-paclitaxel and FOLFOX in people with Cancer of Stomach, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 7 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 15 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe LOUVET (33 1 56 61 60 35, christophe.louvet@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathological response rate (time frame: after three months of neoadjuvant 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 27 Feb 2019.