Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
Metastatic Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Drug: Erlotinib Hydrochloride
Drug: Gemcitabine Hydrochloride
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients With Advanced Pancreatic Carcinoma|
- Maximum tolerated dose of gemcitabine hydrochloride and dasatinib given together with erlotinib hydrochloride, determined by incidence of dose-limiting toxicity graded according to NCI CTCAE v 4.0 [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: Yes ]
- Overall survival (OS) [ Time Frame: The time from enrollment until the time of death due to any cause, assessed up to 6 years ] [ Designated as safety issue: No ]The OS curves will be estimated by the Kaplan-Meier method. Median OS and its 95% confidence intervals will be estimated.
- Progression free survival (PFS) [ Time Frame: The time from enrollment until the first occurrence of radiographic or clinical evidence of disease progression or death due to any cause, assessed up to 6 years ] [ Designated as safety issue: No ]The PFS curves will be estimated by the Kaplan-Meier method. Median PFS and its 95% confidence intervals will be estimated.
- Response duration [ Time Frame: The time from when measurement criteria are met for complete response or partial response (whichever is first recorded) until the date that recurrent or progressive disease is objectively documented, assessed up to 6 years ] [ Designated as safety issue: No ]The response duration for the responders will be summarized using mean, median and standard deviation.
- Response rate, assessed according to RECIST [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]The response rate and its 95% confidence interval will be calculated using the exact binominal method.
- Serious and other significant adverse events (AEs), graded according to NCI CTCAE v 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]The patient incidence of AEs will be summarized by preferred term, severity and relationship to study drug. Cross tabulations will be provided to summarize frequencies of abnormalities.
|Study Start Date:||July 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gemcitabine, dasatinib, erlotinib)
Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1, 8, and 15, and dasatinib PO QD and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: Erlotinib Hydrochloride
Other Names:Drug: Gemcitabine Hydrochloride
I. To determine the maximum tolerated dose (also phase II recommended dose) of the combination of gemcitabine (gemcitabine hydrochloride), erlotinib (erlotinib hydrochloride) and dasatinib in patients with advanced pancreatic adenocarcinoma.
I. To determine the safety profile of the combination of gemcitabine, erlotinib and dasatinib.
II. To evaluate the response rate and response duration of advanced pancreatic adenocarcinoma treated with dasatinib, erlotinib and gemcitabine.
III. To determine progression-free survival and overall survival for this group of patients.
IV. To determine the utility of advanced magnetic resonance imaging techniques to assess in vivo effects of therapy (changes in tumor vascularity, cellularity).
V. To assess the use of serum markers as predictors of response and outcome.
OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride and dasatinib.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30-60 minutes on days 1, 8, and 15, and dasatinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 4 weeks thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660971
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Dana Cardin||Vanderbilt University/Ingram Cancer Center|