Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer
Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: gemcitabine hydrochloride; tanespimycin
Intervention description: 750 mg/m2 Given IV; 154 mg/m2 Given IV
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying three different schedules of gemcitabine
      hydrochloride and tanespimycin to see how well they work in treating patients with stage IV
      pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and
      tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more tumor cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed pancreatic adenocarcinoma

               -  Clinical stage IV disease

          -  No known brain metastases

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Absolute Neutrophil Count (ANC) ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin normal

          -  Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)

          -  Creatinine normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Ejection fraction > 40% by echocardiogram

               -  Patients who received prior anthracyclines must have a normal ejection fraction
                  by echocardiogram

          -  Corrected QT interval (QTc) < 500 msec

          -  Pulse oximetry > 88% on room air at rest and after gentle exercise (according to Group
             Medicare Guidelines)

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to tanespimycin (17-AAG) or gemcitabine hydrochloride

          -  No known allergy to eggs

          -  No concurrent uncontrolled illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirements

          -  No active ischemic heart disease within the past 12 months

          -  No history of uncontrolled dysrhythmias

          -  No congenital long QT syndrome

          -  No left bundle branch block

          -  No other significant cardiac disease, including any of the following:

               -  New York Heart Association class III or IV heart failure

               -  Myocardial infarction within the past year

               -  Poorly controlled angina

               -  Uncontrolled dysrhythmias

               -  History of serious ventricular arrhythmia (ventricular tachycardia or ventricular
                  fibrillation ≥ 3 beats in a row)

          -  No clinically significant interstitial lung disease

          -  No symptomatic pulmonary disease requiring medication, including any of the following:

               -  Dyspnea

               -  Dyspnea on exertion

               -  Paroxysmal nocturnal dyspnea

               -  Significant pulmonary disease requiring oxygen*, including chronic
                  obstructive/restrictive pulmonary disease

          -  No pulmonary or cardiac symptoms ≥ grade 2

          -  No history of cardiac or pulmonary toxicity after receiving anthracyclines (e.g.,
             doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride,
             bleomycin, or vincristine)

          -  No prior chemotherapy for metastatic disease

          -  No prior radiotherapy to the chest

          -  No prior radiotherapy that potentially included the heart in the field (e.g.,mantle
             radiotherapy)

          -  More than 3 months since prior adjuvant chemotherapy or chemotherapy for locally
             advanced disease

          -  More than 3 weeks since prior radiotherapy

          -  No concurrent medications that prolong or may prolong QTc

          -  No concurrent antiarrhythmic drugs

          -  No concurrent prophylactic colony-stimulating factors

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy