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NCT Number: NCT01971034

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Advanced or Metastatic Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ICESP

São Paulo, 01246000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

paclitaxel

Drug

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

metformin

Drug

850mg, PO, every 8 hours, daily.

Primary outcomes

  1. Radiologic control of disease

    Time frame: Every 8 weeks from the date of first dose of treatment until disease progression.

    The radiologic image will be analyzed by RECIST 1.0 criteria.

Secondary outcomes

  1. Time to progression.

    Time frame: Every 8 weeks from the date of first dose of treatment until disease progression.

    Thorax and abdominal computerized tomography and Ca 19.9 tumor marker dosage every 8 weeks until disease progression.

  2. To estimate the biochemical response through the measurement of serum CA19.9 levels.

    Time frame: From the date of first dose of treatment until disease progression.

  3. To evaluate the clinical benefits

    Time frame: Every 4 weeks during the treatment period until disease progression.

    Will be evaluate:

    • ECOG
    • Treatment with opioids
    • Pain
    • Weight

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Official study title

A Prospective Study to Evaluate the Combination of Metformin With Paclitaxel in the Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Important dates

Study start
2011
Primary completion
2012
First posted
Oct 28, 2013
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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