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

NCT01964534 | Unknown Phase 2

• 2 other identifiers: AFUGEM D12-22013-001463-23
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Metastatic Pancreatic Cancer

Keywords

Metastatic; Pancreatic; Cancer; Pancreas; GERCOR; Gemcitabine; LV5FU2; ABI-007; PACLITAXEL ALBUMIN-BOUND PARTICLES

Outcome Measures

Primary Outcomes (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

  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)

• Tumor Response Rate

  Assessed 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 Survival

  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

  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

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

Study Arms (2)

ARM 1 ABI-007 + Gemcitabine

ACTIVE COMPARATOR

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; Drug: Gemcitabine

Arm 2 ABI-007 + simplified LV5FU2

EXPERIMENTAL

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; Drug: simplified LV5FU2

Interventions

ABI-007 DRUG

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

Also known as: Abraxane

ARM 1 ABI-007 + Gemcitabine; Arm 2 ABI-007 + simplified LV5FU2

Gemcitabine DRUG

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

Also known as: Gemzar

ARM 1 ABI-007 + Gemcitabine

simplified LV5FU2 DRUG

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)

Arm 2 ABI-007 + simplified LV5FU2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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).

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead
• Celgene Corporation: collaborator

Study Sites (15)

Institut de cancérologie de l'Ouest - Paul Papin

Angers, France

Location

Institut Sainte Catherine

Avignon, France

Location

Hôpital Avicenne

Bobigny, France

Location

Hôpital Beaujon

Clichy, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

CHU la Timone

Marseille, France

Location

Centre Hospitalier Layné

Mont-de-Marsan, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CHU de Reims Hôpital Robert Debré

Reims, France

Location

Institut de Cancérologie de l'Ouest - Réné Gauducheau

Saint-Herblain, 44805, France

Location

Hôpital Trousseau - CHRU Tours

Tours, France

Location

Related Publications (2)

• 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.

  PMID: 28397697 DERIVED

• 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.

  PMID: 26445094 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jean-Baptiste Bachet, MD

  Hôpital La Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: December 12, 2013
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

FR (15)