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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gemcitabine

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