Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: capecitabine; Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: docetaxel; Drug: gemcitabine hydrochloride

• Registration Number: NCT00966706
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, 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 whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer.

PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.

Detailed Description

OBJECTIVES:

* Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.

* Evaluate the activity and toxicity of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

* Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

* Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may then undergo surgery if the tumor becomes resectable.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2009-04
• Status Verified: 2009-08
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Completion: 2009-10
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	epirubicin hydrochloride	Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II	gemcitabine hydrochloride	Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm I	gemcitabine hydrochloride	Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm I	cisplatin	Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm I	capecitabine	Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II	capecitabine	Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm I	docetaxel	Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II	cisplatin	Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-free survival at 6-months	every 2 months during therapy; every 3 months thereafter	CT scan

Secondary Outcome Measures

Name	Time	Method
Overall survival	monthly
Response rate	every 2 months during therapy; every 3 months thereafter	CT scan
Toxicity	every 2 weeks during therapy	outpatient visit

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milan, Italy