Clinical trial NCT01167738: Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer
Official title: A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival at 6 months
timeFrame: every 2 months
Secondary outcomes:
measure: Overall survival
timeFrame: every 14 days during therapy; every 3 months thereafter
measure: Response rate
timeFrame: every 2 months
measure: Toxicity
timeFrame: every 2 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Scientifico H. San Raffaele
Study officials:
affiliation: Istituto Scientifico H. San Raffaele
name: Michele Reni, MD
role: PRINCIPAL_INVESTIGATOR
References: