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

Sponsor
UNICANCER
Study ID
NCT00112658
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • fluorouracil — DRUG
  • gemcitabine hydrochloride — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG

Study Details

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.

Key Dates

Start date
Nov 30, 2004
Status verified
Mar 2021
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
342 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Folfirinox
  • Active Comparator: Gemcitabine

Primary Outcome Measure

Objective response rate (Phase II)

Related Studies