Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Phase 3

Completed

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

• Registration Number: NCT00303758
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

* Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.

Secondary

* Compare progression-free survival of patients treated with these regimens.

* Compare the toxicity of these regimens in these patients.

* Compare the quality of life of patients treated with these regimens.

* Compare the percentage of these patients needing second-line therapy.

* Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.

Quality of life is assessed at baseline and then every 2 months.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Status Verified: 2006-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LV5FU2 simplifié + cisplatine puis gemcitabine si progression	leucovorin calcium	LV5FU2 simplifié + cisplatine puis gemcitabine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression	cisplatin	gemcitabine puis LV5FU2 simplifié + cisplatine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression	gemcitabine hydrochloride	LV5FU2 simplifié + cisplatine puis gemcitabine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression	fluorouracil	gemcitabine puis LV5FU2 simplifié + cisplatine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression	cisplatin	LV5FU2 simplifié + cisplatine puis gemcitabine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression	fluorouracil	LV5FU2 simplifié + cisplatine puis gemcitabine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression	gemcitabine hydrochloride	gemcitabine puis LV5FU2 simplifié + cisplatine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression	leucovorin calcium	gemcitabine puis LV5FU2 simplifié + cisplatine si progression

Primary Outcome Measures

Name	Time	Method
Overall survival	2012

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	2012
Quality of life	2012
Percentage of patients needing second-line therapy	2012
Duration of hospitalization	2012
Toxicity	2012

Trial Locations

Locations (46)

Centre Hospitalier d'Abbeville; 🇫🇷 Abbeville, France

Hopital Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier de Blois; 🇫🇷 Blois, France

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

Centre Hospitalier Universitaire Ambroise Pare - Boulogne; 🇫🇷 Boulogne, France

C.H. Bourg En Bresse; 🇫🇷 Bourg En Bresse, France

Centre Hospitalier Pierre Oudot; 🇫🇷 Bourgoin-Jallieu, France

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

Centre Hospitalier de Chalons-en-Champagne; 🇫🇷 Chalons-en-Champagne, France

CHR Clermont Ferrand, Hotel dieu; 🇫🇷 Clermont-Ferrand, France

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