Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

NCT01971034 | Completed Phase 2

• 1 other identifier: NP 96/2010
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to 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

  Every 4 weeks during the treatment period until disease progression.

Study Arms (1)

Paclitaxel and Metformin

EXPERIMENTAL

Drug: Paclitaxel; Drug: Metformin

Interventions

Paclitaxel DRUG

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

Paclitaxel and Metformin

Metformin DRUG

850mg, PO, every 8 hours, daily.

Paclitaxel and Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
• Previously treatment with gemcitabine as adjuvant or metastatic disease.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246000, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Paclitaxel; Metformin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Biguanides; Guanidines; Amidines

Study Officials

• Rachel SP Riechelmann, MD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: October 28, 2013
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

BR (1)