Expired Study
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Rochester, Minnesota 55905


Purpose:

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


Study summary:

PRIMARY OBJECTIVES: I. To assess the effect of gemcitabine hydrochloride and tanespimycin (17-AAG) on 6-month survival rate in patients with stage IV pancreatic adenocarcinoma. SECONDARY OBJECTIVES: I. To determine the overall survival of these patients. II. To determine the time to disease progression (TTP) in these patients. III. To determine the confirmed response rate and duration of response in these patients. IV. To determine the time to treatment failure in these patients. V. To determine the adverse events in these patients. TERTIARY OBJECTIVES: I. To determine the effects of treatment on molecular targets, such as CDK4, akt, phospho-akt, Hsp90, Hsp70, and CHK1, and correlate these with clinical endpoints, including survival at 6 months, TTP, response rate, and overall survival. II. To determine the effect of gemcitabine hydrochloride metabolizing enzyme genotype on toxicity, and clinical outcome. OUTLINE: This is a multicenter study. Patients are stratified according to Eastern Cooperative Oncology Group (ECOG) performance status (0, 1, or 2). Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on day 9 of course one. ARM II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9 of course one. ARM III: Patients receive gemcitabine hydrochloride IV over 30 minutes on day 8 and tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and periodically during treatment for pharmacogenetic studies. Tumor tissue samples that are available are also collected for laboratory studies. Samples are analyzed for number of circulating tumor cells, levels of intracellular targets (e.g., CDK4, akt, phospho-akt, Hsp90, Hsp70, and CHK1), single nucleotide DNA polymorphisms, and Vav1 expression. Samples are analyzed by reverse transcriptase-polymerase chain reaction, immunofluorescence, and immunohistochemistry. After completion of study treatment, patients are followed periodically for up to 2 years.


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


Study is Available At:


Original ID:

NCI-2009-00156


NCT ID:

NCT00577889


Secondary ID:

MC0542


Study Acronym:


Brief Title:

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


Official Title:

A Phase II Trial of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert McWilliams
Principal Investigator
Mayo Clinic

Study Dates

Start Date:March 2008
Completion Date:May 2013
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:July 23, 2014
First Received Date:December 19, 2007
First Results Date:September 20, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall Survival Time
Time Frame:Assessed up to 2 years from registration
Safety Issues:False
Description:Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.
Outcome Type:Secondary Outcome
Measure:Time to Disease Progression
Time Frame:Time from registration to documentation of disease progression, assessed up to 2 years
Safety Issues:False
Description:The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier. Complete Response (CR): Di
Outcome Type:Secondary Outcome
Measure:Confirmed Response Rate
Time Frame:2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment
Safety Issues:False
Description:A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meie
Outcome Type:Primary Outcome
Measure:Six Month Survival Rate
Time Frame:6 months
Safety Issues:False
Description:A patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated ac

Study Interventions

Intervention Type:Drug
Name:gemcitabine hydrochloride
Description:750 mg/m2 Given IV
Arm Name:Arm I (combination chemotherapy)
Other Name:dFdC
Intervention Type:Drug
Name:tanespimycin
Description:154 mg/m2 Given IV
Arm Name:Arm I (combination chemotherapy)
Other Name:17-AAG

Study Arms

Study Arm Type:Experimental
Arm Name:Arm III (combination chemotherapy)
Description:Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Study Arm Type:Experimental
Arm Name:Arm II (combination chemotherapy)
Description:Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Study Arm Type:Experimental
Arm Name:Arm I (combination chemotherapy)
Description:Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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