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

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin

• Registration Number: NCT00112658
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-06-02
• Study First Submitted QC: 2005-06-02
• Study First Posted: 2005-06-03
• Primary Completion: 2010-06
• Study Completion: 2010-06-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folfirinox	irinotecan hydrochloride	-
Folfirinox	leucovorin calcium	-
Folfirinox	oxaliplatin	-
Gemcitabine	gemcitabine hydrochloride	-
Folfirinox	fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (Phase II)
Survival (Phase III)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (Phase III)
Toxicity
Progression-free survival (Phase III)
Quality of life (Phase III)

Trial Locations

Locations (54)

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, France

Hopital Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier General; 🇫🇷 Belfort, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Hopital Avicenne; 🇫🇷 Bobigny, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Centre Hospitalier Docteur Duchenne; 🇫🇷 Boulogne Sur Mer, France

Hopital Ambroise Pare; 🇫🇷 Marseille, France

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