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

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

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: ABI-007 Drug: Gemcitabine Drug: simplified LV5FU2 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : July 2017


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 Name: Abraxane

Drug: Gemcitabine
1000 mg/m² IV /30min (day 1, day 8, day 15)
Other Name: 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 Name: 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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Duration of disease control (DDC) [ Time Frame: Assessed up to 30 months after the beginning of the study ]
  3. 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. ]
  4. 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

  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT01964534


Locations
Layout table for location information
France
Institut de cancérologie de l'Ouest - Paul Papin
Angers, France
Institut Sainte Catherine
Avignon, France
Hôpital Avicenne
Bobigny, France
Hôpital Beaujon
Clichy, France
Hôpital Henri Mondor
Créteil, France
Hôpital Privé Jean Mermoz
Lyon, France
CHU la Timone
Marseille, France
Centre Hospitalier Layné
Mont de Marsan, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
Hôpital Saint Antoine
Paris, France
Institut Mutualiste Montsouris
Paris, France
CHU de Reims Hôpital Robert Debré
Reims, France
Institut de Cancérologie de l'Ouest - Réné Gauducheau
Saint Herblain, France, 44805
Hôpital Trousseau - CHRU Tours
Tours, France
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Celgene Corporation
Investigators
Layout table for investigator information
Principal Investigator: Jean-Baptiste Bachet, MD Hôpital La Pitié-Salpêtrière

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT01964534     History of Changes
Other Study ID Numbers: AFUGEM D12-2
2013-001463-23 ( EudraCT Number )
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
Metastatic
Pancreatic
Cancer
Pancreas
GERCOR
Gemcitabine
LV5FU2
ABI-007
PACLITAXEL ALBUMIN-BOUND PARTICLES
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators