Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Phase 2

Completed

• Conditions: Pancreatic Adenocarcinoma Advanced or Metastatic
• Interventions: Drug: Paclitaxel; Drug: Metformin

• Registration Number: NCT01971034
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-06
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel and Metformin	Paclitaxel	-
Paclitaxel and Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Radiologic control of disease	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 Outcome Measures

Name	Time	Method
Time to progression.	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.
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	Every 4 weeks during the treatment period until disease progression.	Will be evaluate: * ECOG; * Treatment with opioids; * Pain; * Weight

Trial Locations

Locations (1)

ICESP; 🇧🇷 Sao Paulo, SP, Brazil