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Clinical Trial Record

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Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

2013-12-12

2017-02

2017-07

114

Study Overview

Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.

Gemcitabine alone or the triplet combination of 5FU, irinotecan and oxaliplatin (FOLFIRINOX)are the reference 1st line treatment for metastatic pancreatic cancer. The aim of the AFUGEM study is to evaluate the efficacy of weekly ABI-007 in combination with weekly gemcitabine or with fortnightly simplified LV5FU2 regimen in terms of progression-free survival in patients with previously untreated metastatic pancreatic cancer. ABI-007 has been approved for commercialization in 38 countries, including the US, Canada, the EU, Australia, China, India and Korea for the treatment of women with metastatic breast cancer. ABI-007 alone and in combination is being evaluated in a number of cancers, including metastatic melanoma, non-small cell lung cancer, pancreatic cancer, and other solid tumors. Conditions which are responsive to paclitaxel such as non-hematological solid tumor malignancies are good clinical candidates for treatment with ABI-007.

  • Metastatic Pancreatic Cancer
  • DRUG: ABI-007
  • DRUG: Gemcitabine
  • DRUG: simplified LV5FU2
  • AFUGEM D12-2
  • 2013-001463-23 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2013-10-15  

N/A  

2017-01-30  

2013-10-15  

N/A  

2017-01-31  

2013-10-17  

N/A  

2017-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: ARM 1 ABI-007 + Gemcitabine

ABI-007 : 125mg/m² IV / 30min (day 1, day 8, day 15) Gemcitabine : 1000mg/m² IV /30 min (day 1, day 8, day 15) One cycle every four weeks treatment until progression or limiting toxicity

DRUG: ABI-007

  • ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)

DRUG: Gemcitabine

  • 1000 mg/m² IV /30min (day 1, day 8, day 15)
EXPERIMENTAL: Arm 2 ABI-007 + simplified LV5FU2

ABI-007 : 125mg/m² IV /30 min (day 1, day 15) folinic acid : 400mg/m² IV /2h (day 1, day 15) Bolus 5-FU : 400mg/m² IV /15min 5-FU infusion : 2400mg/m² IV / 46h (day 1-2, day 15-16) One cycle every four weeks Treatment until progression or limiting toxicit

DRUG: ABI-007

  • ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)

DRUG: simplified LV5FU2

  • Folinic acid: 400 mg/m² IV /2h (day 1, day 15) Bolus 5-FU: 400 mg/m² IV /15min (day 1, day 15) 5-FU infusion: 2400 mg/m² IV /46h (day 1-2, day 15-16)
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progression-free survival (PFS)To evaluate the efficacy of weekly ABI-007 in combination with weekly gemcitabine or with fortnightly simplified LV5FU2 regimen in terms of progression-free survival in patients with previously untreated metastatic pancreatic cancertime interval from randomization to the date of first documented disease progression or death from any cause, whichever occurs first.Assessed at 4 months.
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Tumor Response RateAssessed using RECIST version 1.1Assessed every 2 months during treatment period (- Estimated treatment duration per patient : 6 months).
Duration of disease control (DDC)Assessed up to 30 months after the beginning of the study
Overall Survivaltime interval from inclusion to the date of death from any cause. Assessed up to 30 months after the beginning of the study.
Quality of lifeEORTC QLQ C-30Assessed from study entry to 1 month after last study drug administration and up to 30 months after the beginning of the study.
Number of Adverse EventsTo evaluate the safety profile of ABI-007 in combination with sLV5FU2 (NCI CTCAE v4.0)Assessed from study entry to 1 month after last study drug administration, assessed up to 30 months after the beginning of the study

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Signed and dated informed consent, and willing and able to comply with protocol requirements, 2. Histologically or cytologically proven adenocarcinoma of the pancreas, 3. Metastatic disease confirmed (stage IV), 4. No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months), 5. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 guidelines, 6. Age ≥18 years, 7. ECOG Performance status (PS) 0-2, 8. Hematological status: neutrophils (ANC) >1.5x109/L; platelets >100x109/L; haemoglobin ≥9g/dL, 9. Adequate renal function: serum creatinine level <150µM, 10. Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (≤5xULN in case of liver metastases) 11. Total bilirubin ≤1.5 x ULN, albumin ≥25g/L 12. Baseline evaluations performed before randomization: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization, 13. 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 prior to starting ABI-007 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, 14. Registration in a national health care system (CMU included for France).
    Exclusion Criteria:
    1. History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy) 2. Local or locally advanced disease (stage I to III), 3. Patient uses warfarin, 4. Uncontrolled hypercalcemia, 5. Pre-existing permanent neuropathy (NCI grade ≥2), 6. Known dihydropyrimidine dehydrogenase (DPD) deficiency, 7. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), 8. Treatment with any other investigational medicinal product within 28 days prior to study entry, 9. 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), 10. Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C. 11. History or active interstitial lung disease (ILD), 12. 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, 13. Patients with known allergy to any excipient of study drugs, 14. Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Celgene Corporation
  • PRINCIPAL_INVESTIGATOR: Jean-Baptiste Bachet, MD, Hôpital La Pitié-Salpêtrière

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Bachet JB, Hammel P, Desrame J, Meurisse A, Chibaudel B, Andre T, Debourdeau P, Dauba J, Lecomte T, Seitz JF, Tournigand C, Aparicio T, Meyer VG, Taieb J, Volet J, Monier A, Bonnetain F, Louvet C. Nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil as first-line therapy for metastatic pancreatic adenocarcinoma (AFUGEM GERCOR): a non-comparative, multicentre, open-label, randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2017 May;2(5):337-346. doi: 10.1016/S2468-1253(17)30046-8. Epub 2017 Feb 28.
  • Bachet JB, Chibaudel B, Bonnetain F, Validire P, Hammel P, Andre T, Louvet C; GERCOR group. A randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic cancer: the AFUGEM GERCOR trial. BMC Cancer. 2015 Oct 6;15:653. doi: 10.1186/s12885-015-1656-4.
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