Treatment Of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Study Overview

Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

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.

N/A

Pancreatic Adenocarcinoma Advanced or Metastatic

DRUG: Paclitaxel
DRUG: Metformin

NP 96/2010

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-09-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-05-14
First Submitted that Met QC Criteria 2013-10-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-05-16
First Posted (ESTIMATED) 2013-10-28	Results First Posted N/A	Last Verified 2014-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Paclitaxel and Metformin	DRUG: Paclitaxel 80 mg/m2, IV, Day 1, Day 8 and Day 15. DRUG: Metformin 850mg, PO, every 8 hours, daily.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Paclitaxel and Metformin

DRUG: Paclitaxel

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

DRUG: Metformin

850mg, PO, every 8 hours, daily.

Primary Outcome Measures	Measure Description	Time Frame
Radiologic control of disease	The radiologic image will be analyzed by RECIST 1.0 criteria.	Every 8 weeks from the date of first dose of treatment until disease progression.

Secondary Outcome Measures	Measure Description	Time Frame
Time to progression.	Thorax and abdominal computerized tomography and Ca 19.9 tumor marker dosage every 8 weeks until disease progression.	Every 8 weeks from the date of first dose of treatment until disease progression.
To estimate the biochemical response through the measurement of serum CA19.9 levels.		From the date of first dose of treatment until disease progression.
To evaluate the clinical benefits	Will be evaluate: * ECOG * Treatment with opioids * Pain * Weight	Every 4 weeks during the treatment period until disease progression.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
Previously treatment with gemcitabine as adjuvant or metastatic disease.
Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
At least 10 weeks of life expectation.
Adequate organ function defined as:

Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
Total Bilirubin ≤ 2,0 x ULN
Absolute neutrophil count ≥ 1,500/ mm3
Platelets ≥100.000/ mm3
Hemoglobin ≥ 8,0 g/dl
Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
Signed written informed consent.

Major surgical procedure within 4 weeks of the beginning of the treatment.
History of serious clinical or psychiatric disease.
Symptomatic hypoglycemia at the screening visit.
Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
Treatment with any anti-cancer investigational drug.
Treatment with any IGF-I or IGFR-I
Treatment with metformin within 12 months prior to commencing study treatment
For female patients, current pregnancy and/or lactation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Rachel SP Riechelmann, MD, Instituto do Cancer do Estado de São Paulo

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record