Combination Chemotherapy As First-Line Therapy In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer. PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

OBJECTIVES: Primary * Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II) * Compare the survival of patients treated with these regimens. (Phase III) Secondary * Compare the toxicity of these regimens in these patients. * Compare progression-free survival of patients treated with these regimens. (Phase III) * Compare the overall response rate in patients treated with these regimens. (Phase III) * Compare quality of life of patients treated with these regimens. (Phase III) OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days. * Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days. PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.

Pancreatic Cancer

DRUG: fluorouracil
DRUG: gemcitabine hydrochloride
DRUG: irinotecan hydrochloride
DRUG: leucovorin calcium
DRUG: oxaliplatin

CDR0000430100
FRE-FNCLCC-ACCORD-11/0402
EU-20512

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 2005-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-03-05
First Submitted that Met QC Criteria 2005-06-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-03-08
First Posted (ACTUAL) 2005-06-03	Results First Posted N/A	Last Verified 2021-03

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:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Folfirinox	DRUG: fluorouracil DRUG: irinotecan hydrochloride DRUG: leucovorin calcium DRUG: oxaliplatin
ACTIVE_COMPARATOR: Gemcitabine	DRUG: gemcitabine hydrochloride

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Folfirinox

DRUG: fluorouracil

DRUG: irinotecan hydrochloride

DRUG: leucovorin calcium

DRUG: oxaliplatin

ACTIVE_COMPARATOR: Gemcitabine

DRUG: gemcitabine hydrochloride

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (Phase II)
Survival (Phase III)

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity
Progression-free survival (Phase III)
Quality of life (Phase III)
Overall response rate (Phase III)

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:

Histologically or cytologically confirmed adenocarcinoma of the pancreas

No other pancreatic tumor type, including either of the following:

Neuroendocrine tumor
Acinar cell tumor
Metastatic disease
Measurable disease in an area not previously irradiated
No cerebral metastases or meningeal involvement of the tumor

18 to 75

WHO 0-1

Not specified

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)

Creatinine < 120 mmol/L

No prior myocardial infarction
No prior angina
No uncompensated cardiac or coronary insufficiency
No symptomatic arrhythmia

No prior inflammatory bowel disease
No prior chronic diarrhea
No unresolved symptomatic occlusion or subocclusion of the bowel

Not pregnant or nursing
Fertile patients must use effective contraception
No ongoing active infection
No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No contraindication to study treatment
No other serious medical disorder that would preclude study treatment
No psychiatric disorder or social or geographic situation that would preclude study participation
Not detained or under the guardianship of another person

Not specified

No prior chemotherapy

Not specified

No prior radiotherapy

Not specified

No concurrent participation in another clinical trial using therapeutic experimental agents

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Thierry Conroy, MD, Centre Alexis Vautrin

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

Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.
Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.

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