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

NCT01167738 | Terminated Phase 2

• 3 other identifiers: CDR0000681691PACT-172010-020979-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 6 months

  CT scan

  every 2 months

Secondary Outcomes (3)

• Overall survival

  every 14 days during therapy; every 3 months thereafter

• Response rate

  every 2 months

• Toxicity

  every 2 weeks

Study Arms (2)

PEXG regimen + metformin

EXPERIMENTAL

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

Drug: capecitabine; Drug: cisplatin; Drug: epirubicin; Drug: gemcitabine; Drug: metformin

PEXG regimen

ACTIVE COMPARATOR

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

Drug: capecitabine; Drug: cisplatin; Drug: epirubicin; Drug: gemcitabine

Interventions

capecitabine DRUG

1250 mg/mq days 1-28 every 4 weeks

Also known as: XELODA

PEXG regimen; PEXG regimen + metformin

cisplatin DRUG

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

Also known as: cisplatino TEVA

PEXG regimen; PEXG regimen + metformin

epirubicin DRUG

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

Also known as: farmorubicina

PEXG regimen; PEXG regimen + metformin

gemcitabine DRUG

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

Also known as: GEMZAR

PEXG regimen; PEXG regimen + metformin

metformin DRUG

2 g days 1-28 every 4 weeks

Also known as: glucophage

PEXG regimen + metformin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Cisplatin; Epirubicin; Gemcitabine; Metformin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Michele Reni, MD

  Istituto Scientifico H. San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

IT (1)