Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer

This is an interventional treatment trial for Adenocarcinoma of the Pancreas Read More

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