Status:
TERMINATED
Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment for pancreatic cancer. PURPOSE: This phase I trial is studying how well pioglitazone works as second-line ...
Detailed Description
OBJECTIVES: Primary * To describe changes in markers of insulin resistance, including serum adiponectin levels, standard glucose tolerance testing, and fasting serum glucose and insulin levels, in p...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Previously treated disease
- Disease progression after first-line gemcitabine hydrochloride-based chemotherapy
- Radiologically measurable disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Serum creatinine \< 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 45 mL/min
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No NYHA class III-IV congestive heart failure
- No unstable angina
- No second malignancy except for localized nonmelanoma skin cancer
- No psychiatric or addictive disorders that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed
- More than 12 months since prior and no other concurrent thiazolinediones
- More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
March 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00867126
Start Date
March 2 2009
End Date
February 1 2012
Last Update
November 26 2018
Active Locations (1)
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1
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390