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NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma (FOXAGAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02486601
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Cancer of Stomach Drug: nab-paclitaxel Drug: FOLFOX Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma
Study Start Date : June 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: nab-paclitaxel + FOLFOX
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)
Drug: nab-paclitaxel
nab-paclitaxel : 150 mg/m2 D1 every 2 weeks
Other Name: ABRAXANE

Drug: FOLFOX
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




Primary Outcome Measures :
  1. Complete pathological response rate [ Time Frame: after three months of neoadjuvant chemotherapy ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall Survival (OS) [ Time Frame: time interval form the inclusion to the date of the death from any cause up to 7 years ]
  3. Health related to Quality of Life (QoL) [ Time Frame: up to 8 months ]
  4. 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 ]
  5. Assessment of biomarkers when appropriate [ Time Frame: 1 day of biopsie from diagnosis, and tumor from surgery ]
    such as SPARC, TS, DPD, ERCC1

  6. Assessment of genetic polymorphism involved in tumor-response when appropriate [ Time Frame: 28 days after last study treatment ]
    CYP2A6, TS, DPD, ERCC1, ERCC2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,
  • 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).

Exclusion Criteria:

  • 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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486601


Contacts
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Contact: Christophe LOUVET 33 1 56 61 60 35 christophe.louvet@imm.fr

Locations
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France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact    33-3-8166-8393      
Principal Investigator: Stéphano KIM         
Centre Hospitalier Universitaire Henri Mondor Recruiting
Creteil, France, 94000
Contact    33-1-4981-2579      
Principal Investigator: Christophe TOURNIGAND         
Centre Léon Bérard Recruiting
Lyon, France
Contact: E         
Principal Investigator: Christelle de la FOUCHARDIERE         
Hôpital Privé Jean Mermoz Recruiting
Lyon, France
Principal Investigator: Gérard LLEDO         
CHU Pitie-Salpetriere Recruiting
Paris, France, 75651
Contact    33-1-42-16-00-00      
Principal Investigator: Jean-Baptiste BACHET         
Hopital Saint Antoine Recruiting
Paris, France
Principal Investigator: Thierry ANDRE         
Institut Mutualiste Montsouris Recruiting
Paris, France
Contact: Christophe, PhD         
Principal Investigator: Christophe LOUVET, PhD         
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Celgene Corporation
Investigators
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Principal Investigator: Christophe LOUVET Institut Mutualiste Montsouris
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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT02486601    
Other Study ID Numbers: FOXAGAST -D14-1
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action