Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

NCT ID: NCT01971034

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30

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.

Conditions

Pancreatic Adenocarcinoma Advanced or Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel and Metformin

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

850mg, PO, every 8 hours, daily.

Interventions

Paclitaxel

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

Intervention Type: DRUG

Metformin

850mg, PO, every 8 hours, daily.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel SP Riechelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

ICESP

São Paulo, São Paulo, Brazil

Countries

Brazil

Related Links

http://www.icesp.org.br

Related Info

Other Identifiers

NP 96/2010

Identifier Type: -

Identifier Source: org_study_id