Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer

NCT ID: NCT01167738

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-04-30

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. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.

PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.

Detailed Description

OBJECTIVES:

Primary

• To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.

Secondary

• To assess the overall survival of patients treated with this regimen.
• To assess the response rate in patients treated with this regimen.
• To assess the duration of response in patients treated with this regimen.
• To assess the toxicity in patients treated with this regimen.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cisplatin, epirubicin hydrochloride, and gemcitabine hydrochloride on days 1 and 15. Patients will also receive capecitabine and metformin hydrochloride on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEXG regimen + metformin

cisplatin and epirubicin at 30 mg/mq on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15, Metformin at 2 g days 1-28

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

1250 mg/mq days 1-28 every 4 weeks

cisplatin

Intervention Type: DRUG

30 mg/mq on days 1 and 15 every 4 weeks

epirubicin

Intervention Type: DRUG

30 mg/mq on days 1 and 15 every 4 weeks

gemcitabine

Intervention Type: DRUG

800 mg/mq on days 1 and 15 every 4 weeks

metformin

Intervention Type: DRUG

2 g days 1-28 every 4 weeks

PEXG regimen

cisplatin and epirubicin at 30 mg/mQ on days 1 and 15, capecitabine at 1250 mg/mq days 1-28, gemcitabine at 800 mg/mq on days 1 and 15

Group Type: ACTIVE_COMPARATOR

capecitabine

Intervention Type: DRUG

1250 mg/mq days 1-28 every 4 weeks

cisplatin

Intervention Type: DRUG

30 mg/mq on days 1 and 15 every 4 weeks

epirubicin

Intervention Type: DRUG

30 mg/mq on days 1 and 15 every 4 weeks

gemcitabine

Intervention Type: DRUG

800 mg/mq on days 1 and 15 every 4 weeks

Interventions

capecitabine

1250 mg/mq days 1-28 every 4 weeks

Intervention Type: DRUG

cisplatin

30 mg/mq on days 1 and 15 every 4 weeks

Intervention Type: DRUG

epirubicin

30 mg/mq on days 1 and 15 every 4 weeks

Intervention Type: DRUG

gemcitabine

800 mg/mq on days 1 and 15 every 4 weeks

Intervention Type: DRUG

metformin

2 g days 1-28 every 4 weeks

Intervention Type: DRUG

Other Intervention Names

XELODA; cisplatino TEVA; farmorubicina; GEMZAR; glucophage

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic adenocarcinoma

• Metastatic (stage IV) disease
• Measurable disease
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Not pregnant or nursing
• Adequate bone marrow, liver and kidney function
• No previous or concurrent malignancies at other sites except for surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms without evidence of disease within the past 5 years
• No multiple severe diseases which would compromise safety (i.e., cardiac failure, previous myocardial infarction within the past 4 months, cardiac arrhythmia, or history of psychiatric disabilities)
• No alcohol abuse

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or metformin
• No other concurrent experimental drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Michele Reni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Reni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico H. San Raffaele

Locations

Istituto Scientifico H. San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

PACT-17

Identifier Type: OTHER

Identifier Source: secondary_id

2010-020979-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000681691

Identifier Type: -

Identifier Source: org_study_id