Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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 therapy in treating patients with metastatic pancreatic cancer that progressed after treatment with gemcitabine.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simmons Cancer Center; University of Texas Southwestern Medical Center
• Treatments: Gemcitabine; Pioglitazone

Criteria

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