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Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

NCT01971034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-05-16

No results posted yet for this study

Summary

In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.

Conditions

  • Pancreatic Adenocarcinoma Advanced or Metastatic

Interventions

DRUG

Paclitaxel

80 mg/m2, IV, Day 1, Day 8 and Day 15.

DRUG

Metformin

850mg, PO, every 8 hours, daily.

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Rachel SP Riechelmann, MD · Instituto do Cancer do Estado de São Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971034 on ClinicalTrials.gov