Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01234935
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2010-11-01
Brief Title:
Dasatinib and Gemcitabine Hydrochloride or Gemcitabine Hydrochloride Alone in Treating Patients With Pancreatic Cancer Previously Treated With Surgery
Sponsor:
Translational Oncology Research International
Organization:
Translational Oncology Research International
Study Overview
Official Title:
A Multicenter Open-Label Randomized Phase II Trial of Adjuvant Dasatinib Plus Gemcitabine Versus Single-Agent Gemcitabine in Patients With Resected Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine hydrochloride work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing It is not yet known whether giving dasatinib together with gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating pancreatic cancer PURPOSE This randomized phase II trial is studying how well giving dasatinib together with gemcitabine hydrochloride works compared to giving gemcitabine hydrochloride alone in treating patients with pancreatic cancer previously treated with surgery
Detailed Description:
PRIMARY OBJECTIVES I To compare disease-free survival at 18 months between dasatinib-gemcitabine combination therapy and single-agent gemcitabine SECONDARY OBJECTIVES I To evaluate effects on disease-free survival of the dasatinib-gemcitabine combination therapy compared with gemcitabine alone for adjuvant treatment of resected pancreatic adenocarcinoma II To evaluate effects on overall survival of dasatinib-gemcitabine combination therapy compared with gemcitabine alone for adjuvant treatment of resected pancreatic adenocarcinoma III To evaluate tolerability and safety of the two arms IV To identify potential biological correlates associated with clinical benefit to dasatinib-gemcitabine combination therapy compared with gemcitabine alone OUTLINE Patients are randomized to 1 of 2 treatment arms ARM I Patients receive gemcitabine hydrochloride IV on days 1 8 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity ARM II Patients receive gemcitabine hydrochloride IV on days 1 8 and 15 and oral dasatinib once daily on days 1-28 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity NOTE Courses with dasatinib repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed up every 3 months for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-02190 | None | None | None |