Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer (PACT-9)

San Donato Group (GSD)

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: capecitabine; Drug: gemcitabine hydrochloride; Drug: docetaxel; Drug: cisplatin; Drug: epirubicin hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00966706

CDR0000642240

2005-002586-36 (EudraCT Number)

SRSI-PACT-9 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas

  • Stage III or IV disease

• Measurable disease

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Adequate bone marrow, liver, and kidney function

• Not pregnant or nursing

• No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin

• No multiple severe diseases that can compromise study safety, including any of the following:

  • Cardiac failure
  • Myocardial infarction within the past 4 months
  • Cardiac arrhythmia
  • History of psychiatric disabilities

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for pancreatic cancer
• No other concurrent experimental drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Arm I

Experimental group

Description:

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.

Treatment:

Drug: cisplatin

Drug: docetaxel

Drug: gemcitabine hydrochloride

Drug: capecitabine

Arm II

Experimental group

Description:

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.

Treatment:

Drug: epirubicin hydrochloride

Drug: cisplatin

Drug: gemcitabine hydrochloride

Drug: capecitabine