AzTrials
AzTrials

Metastatic Pancreatic CancerPhase 2AFUGEMNCT01964534

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

A Phase 2 study testing ABI-007, Gemcitabine and simplified LV5FU2 in people with Metastatic Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
ABI-007, Gemcitabine and simplified LV5FU2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
15 sitesFrance
Study dates
12 Dec 2013to Jul 2017
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 pancreas,
  • Metastatic disease confirmed (stage IV),
  • No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months),
  • At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 guidelines,
  • Age ≥18 years,
Show all 14Show fewer
  • ECOG Performance status (PS) 0-2,
  • Hematological status: neutrophils (ANC) >1.5x109/L; platelets >100x109/L; haemoglobin ≥9g/dL,
  • Adequate renal function: serum creatinine level <150µM,
  • Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (≤5xULN in case of liver metastases)
  • Total bilirubin ≤1.5 x ULN, albumin ≥25g/L
  • 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,
  • 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,
  • Registration in a national health care system (CMU included for France).

Who cannot join

  • 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)
  • Local or locally advanced disease (stage I to III),
  • Patient uses warfarin,
  • Uncontrolled hypercalcemia,
  • Pre-existing permanent neuropathy (NCI grade ≥2),
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency,
Show all 14Show fewer
  • 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.
  • History or active interstitial lung disease (ILD),
  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Institut de cancérologie de l'Ouest - Paul Papin

    Angers

  • Institut Sainte Catherine

    Avignon

  • Hôpital Avicenne

    Bobigny

  • Hôpital Beaujon

    Clichy

  • Hôpital Henri Mondor

    Créteil

  • Hôpital Privé Jean Mermoz

    Lyon

  • CHU la Timone

    Marseille

  • Centre Hospitalier Layné

    Mont-de-Marsan

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Pitié-Salpêtrière

    Paris

  • Hôpital Saint Antoine

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • CHU de Reims Hôpital Robert Debré

    Reims

  • Institut de Cancérologie de l'Ouest - Réné Gauducheau

    Saint-Herblain, 44805

  • Hôpital Trousseau - CHRU Tours

    Tours

Other trials in France

About this study

Official title: Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

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

Read the detailed description

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.

Being tested
ABI-007, Gemcitabine, simplified LV5FU2
Keywords
Metastatic, Pancreatic, Cancer, Pancreas, GERCOR, Gemcitabine, LV5FU2, ABI-007, PACLITAXEL ALBUMIN-BOUND PARTICLES
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABI-007Drug

    Also called Abraxane

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

  • GemcitabineDrug

    Also called Gemzar

    1000 mg/m² IV /30min (day 1, day 8, day 15)

  • simplified LV5FU2Drug

    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)

Study groups in NCT01964534
Study groupRoleWhat they receive
ARM 1 ABI-007 + GemcitabineActive comparatorABI-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
Receives: Drug: ABI-007; Drug: Gemcitabine
Arm 2 ABI-007 + simplified LV5FU2ExperimentalABI-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 toxicity
Receives: Drug: ABI-007; Drug: simplified LV5FU2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 cancer

    Measured: time interval from randomization to the date of first documented disease progression or death from any cause, whichever occurs first.Assessed at 4 months.

Secondary outcomes (5)

  1. Tumor Response Rate

    Assessed using RECIST version 1.1

    Measured: Assessed every 2 months during treatment period (- Estimated treatment duration per patient : 6 months).

  2. Duration of disease control (DDC)

    Measured: Assessed up to 30 months after the beginning of the study

  3. Overall Survival

    Measured: time interval from inclusion to the date of death from any cause. Assessed up to 30 months after the beginning of the study.

  4. Quality of life

    EORTC QLQ C-30

    Measured: Assessed from study entry to 1 month after last study drug administration and up to 30 months after the beginning of the study.

  5. Number of Adverse Events

    To evaluate the safety profile of ABI-007 in combination with sLV5FU2 (NCI CTCAE v4.0)

    Measured: Assessed from study entry to 1 month after last study drug administration, assessed up to 30 months after the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2013 (estimated)
  2. Study start12 Dec 2013
  3. Primary completionFeb 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01964534
Sponsor's protocol ID
AFUGEM D12-2
Other IDs
2013-001463-23
Acronym
AFUGEM
Status last verified
Jan 2017
First submitted
15 Oct 2013
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 28397697

  • 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.

    PubMed 26445094

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-007, Gemcitabine and simplified LV5FU2 in people with Metastatic Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 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 14 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

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?

Progression-free survival (PFS) (time frame: time interval from randomization to the date of first documented disease progression or death from any cause, whichever occurs first.Assessed at 4 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01964534, which also lists 2 linked publications.

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 31 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in