Clinical trialPhase 2Terminated
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
- Outcome
- Stopped earlyCompeting studies (Other)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- September 2015
- Expected end
- March 2016
- Enrollment
- 1 participants
- Sites
- 1
- Primary outcomes
- Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy
- Sponsor
- Other
- Results posted
- 2018-07-13
- Last update
- 13 July 2018
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Brief summary public domain (ClinicalTrials.gov)
This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To determine feasibility of preoperative FOLFIRINOX for resectable pancreatic adenocarcinoma. SECONDARY OBJECTIVES: I. To determine safety and toxicity of preoperative FOLFIRINOX. II. To determine response rate. III. To determine proportion achieving major pathologic response - per College of American Pathologists (CAP) criteria. IV. To determine proportion achieving R0 resection. V. To determine perioperative (30-day) mortality. VI. To determine the role of cancer antigen (CA)19.9 as potential prognostic and/or predictive biomarker. VII. To determine progression-free survival. VIII. To determine overall survival. OUTLINE: Patients receive FOLFIRINOX regimen comprising irinotecan hydrochloride intravenously (IV) over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin calcium IV over 120 minutes, and fluorouracil IV over 1-2 minutes and then continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy [Up to 12 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Incidence of Toxicities Greater Than Grade 2, Using the Common Terminology Criteria for Adverse Events Version 4.0 [Up to 30 days after end of treatment or to the day prior to surgery].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Achieving Major Pathologic Response [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Achieving R0 Resection [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Experiencing Perioperative (30-day) Mortality [Up to 30 days].