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

January 30, 2017 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • France
      • Angers, France
        • Institut de Cancerologie de l'Ouest - Paul Papin
      • Avignon, France
        • Institut Sainte Catherine
      • Bobigny, France
        • Hôpital Avicenne
      • Clichy, France
        • Hopital Beaujon
      • Créteil, France
        • Hopital Henri Mondor
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Marseille, France
        • CHU La Timone
      • Mont de Marsan, France
        • Centre Hospitalier Layné
      • Paris, France
        • Hopital Pitie-Salpetriere
      • Paris, France
        • Institut Mutualiste Montsouris
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Reims, France
        • CHU de Reims Hôpital Robert Debré
      • Saint Herblain, France, 44805
        • Institut de cancérologie de l'Ouest - René Gauducheau
      • Tours, France
        • Hôpital Trousseau - CHRU Tours

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / 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)
Other Names:
  • Abraxane
Drug: Gemcitabine
1000 mg/m² IV /30min (day 1, day 8, day 15)
Other Names:
  • Gemzar
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 toxicity
Drug: ABI-007
ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)
Other Names:
  • Abraxane
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response Rate
Time Frame: Assessed every 2 months during treatment period (- Estimated treatment duration per patient : 6 months).
Assessed using RECIST version 1.1
Assessed every 2 months during treatment period (- Estimated treatment duration per patient : 6 months).
Duration of disease control (DDC)
Time Frame: Assessed up to 30 months after the beginning of the study
Assessed up to 30 months after the beginning of the study
Overall Survival
Time Frame: time interval from inclusion to the date of death from any cause. Assessed up to 30 months after the beginning of the study.
time interval from inclusion to the date of death from any cause. Assessed up to 30 months after the beginning of the study.
Quality of life
Time Frame: Assessed from study entry to 1 month after last study drug administration and up to 30 months after the beginning of the study.
EORTC QLQ C-30
Assessed 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 Events
Time Frame: Assessed from study entry to 1 month after last study drug administration, assessed up to 30 months after the beginning of the study
To 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

Collaborators and Investigators

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

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Jean-Baptiste Bachet, MD, Hôpital La Pitié-Salpêtrière

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (ACTUAL)

December 12, 2013

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (ESTIMATE)

October 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFUGEM D12-2
  • 2013-001463-23 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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