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A Pilot Study of Pioglitazone as Second Line Therapy for Patients With Previously Treated Metastatic Adenocarcinoma of the Pancreas With Disease Progression After Gemcitabine Based Chemotherapy


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Pilot Study of Pioglitazone as Second Line Therapy for Patients With Previously Treated Metastatic Adenocarcinoma of the Pancreas With Disease Progression After Gemcitabine Based Chemotherapy


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 patients with previously treated metastatic adenocarcinoma of the pancreas
treated with pioglitazone hydrochloride as second-line therapy.

- To describe changes in weight in these patients.

- To describe changes in ECOG performance status in these patients.

- To describe changes in symptoms and quality of life of these patients using the
validated FACT-Hep scale version 4 questionnaire.

Secondary

- To determine the tumor response as measured by RECIST criteria in these patients.

- To determine the time to disease progression in these patients.

OUTLINE: Patients receive oral pioglitazone hydrochloride once daily on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients complete a quality-of-life questionnaire at baseline, every 4 weeks during therapy,
and then at the completion of therapy.

Patients undergo blood sample collection at baseline, every 4 weeks during therapy, and then
at the completion of therapy for laboratory biomarker studies. Samples are analyzed for
levels of insulin resistance markers (adiponectin, glucose, and insulin).

After completion of study therapy, patients are followed monthly for 6 months and then every
3 months for 2 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Insulin resistance markers as measured by standard glucose tolerance testing and serum adiponectin levels at baseline, every 4 weeks during therapy, and then at the completion of therapy

Safety Issue:

No

Principal Investigator

Yull E. Arriaga, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

Unspecified

Study ID:

CDR0000637622

NCT ID:

NCT00867126

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390