Efficacy of ABI-007 plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients with Metastatic Pancreatic Cancer.

Phase 1

• Conditions: metastatic pancreatic cancer; MedDRA version: 14.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001463-23-FR
• Lead Sponsor: GERCOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 114

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 (ß 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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of Progression free survival;Secondary Objective: - Tumor Response Rate according to RECIST v1.1<br>- Overall Survival<br>- Health related to Quality of Life (EORTC QLQ C-30)<br>- Safety profile (NCI CTCAE v4.0)<br>- Duration of response,<br>- Duration of disease control,<br>- Prognostic and predictive value of SPARC expression when feasible in both arms, hENT1 and dCK expressions in arm 1, and TS expression in arm 2.;Primary end point(s): Progression Free Survival (PFS) ;Timepoint(s) of evaluation of this end point: time interval from randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Tumor response<br>Overall survival<br>Time to Quality of Life (QoL) score deterioration for targeted dimensions;Timepoint(s) of evaluation of this end point: Tumor response will be assessed every 2 months using RECIST version 1.1. <br>Overall survival is defined as the time interval from randomization to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.<br>QoL will be assessed at D1 of each cycle.