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

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas, stage IV pancreatic cancer

Brief summary

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.

Detailed description

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.

Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T.

2017-09-2019 citations

10.1371/journal.pone.0183288

nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial.

Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A.

2016-04-1613 citations

10.1007/s12325-016-0327-4

Evolution of pain in patients with metastatic pancreatic carcinoma treated with FOLFIRINOX or gemcitabine in a randomized phase III study (ACCORD11/PRODIGE4).

Sophie Gourgou, Marta Jarlier, Antoine Barbieri, Françoise Desseigne, Marc Ychou et al. (8 authors)

Journal of Clinical Oncology2015-05-20

10.1200/jco.2015.33.15_suppl.e15251

FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.

Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M, Groupe Tumeurs Digestives of Unicancer, PRODIGE Intergroup.

2011-05-015,677 citations

10.1056/nejmoa1011923

Interventions

DRUGfluorouracil

DRUGgemcitabine hydrochloride

DRUGirinotecan hydrochloride

DRUGleucovorin calcium

DRUGoxaliplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed) Renal * Creatinine \< 120 mmol/L Cardiovascular * No prior myocardial infarction * No prior angina * No uncompensated cardiac or coronary insufficiency * No symptomatic arrhythmia Gastrointestinal * No prior inflammatory bowel disease * No prior chronic diarrhea * No unresolved symptomatic occlusion or subocclusion of the bowel Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * Not specified Other * No concurrent participation in another clinical trial using therapeutic experimental agents

Design outcomes

Primary

Measure	Time frame
Objective response rate (Phase II)	—
Survival (Phase III)	—

Secondary

Measure	Time frame
Toxicity	—
Progression-free survival (Phase III)	—
Quality of life (Phase III)	—
Overall response rate (Phase III)	—

Countries

France

Outcome results

None listed