Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.
Overview[ - collapse ][ - ]
| Purpose | 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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| Condition | Pancreatic Adenocarcinoma Advanced or Metastatic |
| Intervention | Drug: Paclitaxel Drug: Metformin |
| Phase | Phase 2 |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Responsible Party | Instituto do Cancer do Estado de São Paulo |
| ClinicalTrials.gov Identifier | NCT01971034 |
| First Received | September 6, 2013 |
| Last Updated | October 22, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 6, 2013 |
|---|---|
| Last Updated Date | October 22, 2013 |
| Start Date | June 2011 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Radiologic control of disease [Time Frame: Every 8 weeks from the date of first dose of treatment until disease progression.] [Designated as safety issue: No]The radiologic image will be analyzed by RECIST 1.0 criteria. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure. |
|---|---|
| Official Title | A Prospective Study to Evaluate the Combination of Metformin With Paclitaxel in the Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure. |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Pancreatic Adenocarcinoma Advanced or Metastatic |
| Intervention | Drug: Paclitaxel 80 mg/m2, IV, Day 1, Day 8 and Day 15. Drug: Metformin 850mg, PO, every 8 hours, daily. |
| Study Arm (s) | Experimental: Paclitaxel and Metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 41 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2012 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Rachel SP Riechelmann, MD 55 11 38932000 pesquisa.clinica@icesp.org.br |
| Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01971034 |
|---|---|
| Other Study ID Numbers | NP 96/2010 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Instituto do Cancer do Estado de São Paulo |
| Study Sponsor | Instituto do Cancer do Estado de São Paulo |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Rachel SP Riechelmann, MD Instituto do Cancer do Estado de São Paulo |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| ICESP | Sao Paulo, SP, Brazil, 01246000 Contact: Rachel SP Riechelmann, MD | 55 11 38932000 | pesquisa.clinica@icesp.org.brRecruiting |
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