FIrst Line Treatment Of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

Study Overview

FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

N/A

Metastatic Pancreatic Cancer

DRUG: FOLFIRI.3
DRUG: nab-paclitaxel+ gemcitabine

PRODIGE 37

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-11-26	Results First Submitted 2022-12-22	Last Update Submitted that met QC Criteria 2024-07-05
First Submitted that Met QC Criteria 2016-07-05	Results First Submitted that Met QC Criteria 2024-07-05	Last Update Posted (ACTUAL) 2024-07-09
First Posted (ACTUAL) 2016-07-11	Results First Posted 2024-07-09	Last Verified 2024-07

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: nab-paclitaxel + gemcitabine/FOLFIRI.3 Alternance of : * 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) * follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2	DRUG: FOLFIRI.3 For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Ir DRUG: nab-paclitaxel+ gemcitabine For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
ACTIVE_COMPARATOR: nab-paclitaxel + gemcitabine nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression	DRUG: FOLFIRI.3 For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Ir DRUG: nab-paclitaxel+ gemcitabine For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: nab-paclitaxel + gemcitabine/FOLFIRI.3

Alternance of : * 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) * follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2

DRUG: FOLFIRI.3

For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Ir

DRUG: nab-paclitaxel+ gemcitabine

For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

ACTIVE_COMPARATOR: nab-paclitaxel + gemcitabine

nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression

DRUG: FOLFIRI.3

For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Ir

DRUG: nab-paclitaxel+ gemcitabine

For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Primary Outcome Measures	Measure Description	Time Frame
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization	The primary endpoint was the rate of patients alive and progression-free 6 months after randomization. Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites. Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months. The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.	6 months after randomization

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS):	Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account	Up to 2 years after the treatment start
Best Response	Best response is defined as the best response for each patient regarding imagerie taken during the treatment. Response was evalauted according to RECIST v1.1 over the entire treatment period according the investigator	Up to the end of treatment on the average of 12 months
Progression-free Survival (PFS)	It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news	up to 12 months after randomization

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histological or cytological confirmation of pancreatic adenocarcinoma
Distant metastatic disease
Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
At least one lesion measurable by RECIST v1.1 criteria
Life expectancy> 3 months
No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
Pain must be monitored before inclusion
18 years < age < 75
Performance status: WHO < 2
ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
Patient affiliated to the social security scheme
Patient information and signature of informed consent

- Other types of pancreatic tumours, especially endocrine or acinar cell tumours
Ampulloma
Presence of meningeal or cerebral metastases, bone metastases
Gilbert's syndrome
Presence of neuropathy> grade 1 according to NCIC-CTC 4.0
Contraindications specific to the studied treatments
History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
Significant history of heart or respiratory disease, including any history of interstitial pneumonia
Patient already included in another clinical trial with an experimental molecule
Women who are breast-feeding
Persons deprived of liberty or under guardianship
Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons

Collaborators and Investigators

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

UNICANCER
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

STUDY_CHAIR: Julien TAIEB, Pr, HEGP - PARIS - FRANCE

Publications

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

General Publications

Rinaldi Y, Pointet AL, Khemissa Akouz F, Le Malicot K, Wahiba B, Louafi S, Gratet A, Miglianico L, Laharie H, Bouhier Leporrier K, Thirot Bidault A, Texereau P, Coriat R, Terrebonne E, Gouttebel MC, Malka D, Bachet JB, Lepage C, Taieb J; PRODIGE 37 Investigators/Collaborators. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancerologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX). Eur J Cancer. 2020 Sep;136:25-34. doi: 10.1016/j.ejca.2020.05.018. Epub 2020 Jul 2.

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