Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964534
Recruitment Status : Unknown
Verified January 2017 by GERCOR - Multidisciplinary Oncology Cooperative Group.
Recruitment status was:  Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : January 31, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Tracking Information
First Submitted Date  ICMJE October 15, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date January 31, 2017
Actual Study Start Date  ICMJE December 12, 2013
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01964534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
  • 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
  • Duration of disease control (DDC) [ Time Frame: 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. ]
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
  • 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
  • Duration of disease control (DDC) [ Time Frame: 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. ]
  • 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
  • Safety [ 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer
Official Title  ICMJE Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer
Brief Summary To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Drug: ABI-007
    ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)
    Other Name: Abraxane
  • Drug: Gemcitabine
    1000 mg/m² IV /30min (day 1, day 8, day 15)
    Other Name: Gemzar
  • 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)
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: ABI-007
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Drug: ABI-007
    • Drug: simplified LV5FU2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 15, 2013)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964534
Other Study ID Numbers  ICMJE AFUGEM D12-2
2013-001463-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GERCOR - Multidisciplinary Oncology Cooperative Group
Study Sponsor  ICMJE GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Jean-Baptiste Bachet, MD Hôpital La Pitié-Salpêtrière
PRS Account GERCOR - Multidisciplinary Oncology Cooperative Group
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP