- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01760252
Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Pancreatic Adenocarcinoma Protocol
Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
This is a phase II study evaluating the treatment adherence rate, efficacy and safety of neoadjuvant chemotherapy with capecitabine, oxaliplatin and irinotecan (CAPOXIRI) in patients with resectable (able to be cut out), borderline resectable and locally advanced pancreatic adenocarcinoma. Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that builds on the advancement associated with oxaliplatin, irinotecan, fluorouracil, and folinate (FOLFIRINOX regimen) chemotherapy in patients with metastatic disease. Building on the FOLFIRINOX regimen the use of CAPOXIRI is among the most clinically relevant projects for patients diagnosed with earlier stage pancreatic adenocarcinoma with the goal of improving patient outcomes and advancing our knowledge and understanding of this devastating disease.
The primary end point is the treatment adherence rate (TAR) which is the percentage of patients who complete 75% of the planned treatment (dose) for their diagnostic strata (resectable disease and borderline resectable/locally advanced disease).
Secondary end points are: Overall survival (OS), Disease-free survival (DFS; for those patients who are rendered disease-free by surgical resection), Progression Free Survival (PFS), Response Rate (RR), toxicity, and R0 resection rate (for patients stratified as having resectable disease and borderline resectable disease).
Background and Study Rationale:
It is estimated that 36,800 people will die of pancreatic cancer in the United States in 2010. Surgical resection offers the only chance of cure, but only 15-20% of cases are potentially resectable at present. Furthermore, prognosis is poor, even for those undergoing complete resection. Reported five-year survival rates following pancreatic-duodenectomy (surgery of the small intestine and pancreas) for node-negative disease is 25-30% and for node-positive disease is 10%.
The purpose of this study is to evaluate the effects of the combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) on the disease. This research is being done because we think that this combination, CAPOXIRI, may be better than other combinations used to treat your stage of pancreatic cancer.
A research study like this one has been done which shows that a similar combination of drugs including oxaliplatin, irinotecan and 5-fluorouracil (which is in the same class as capecitabine) can be effective in treating patients with pancreatic cancer who have more advanced disease than you. All of the drugs that are being used in this study have been approved by the FDA (Food and Drug Administration).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Mount Sinai Beth Israel
-
New York, New York, United States, 10018
- St-Lukes Roosevelt Hospital Medical Center
-
New York, New York, United States, 10025
- Beth Israel Comprehensive Care Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is clinically staged as resectable, borderline resectable, or locally advanced as determined by CT criteria.
- Age ≥ 18 years old.
- An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 (Appendix B).
- Patients must give written informed consent as per institutional and federal regulatory requirements.
- An interval between initial diagnosis and consent of ≤ 42 days.
- An interval between consent and initiating protocol-directed therapy of ≤ 14 days.
- CT scan to stratify as resectable versus borderline resectable/locally advanced status within 28 days of initiating protocol-directed therapy.
- A general level of health that would indicate a life expectancy of 5 years, excluding the patient's cancer diagnosis.
- No prior chemotherapy, immunotherapy or radiotherapy for pancreatic adenocarcinoma.
- Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Appendix C).
- Absolute granulocyte count of ≥ 1,500/mm3 and a platelet count of ≥ 100,000/mm3.
- Patients must have adequate liver and renal function defined by a bilirubin of ≤ 2.0 mg/dL (with or without biliary stenting) and a creatinine of ≤ 1.5 mg/dL respectively.
- Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry.
- There must be no extra-pancreatic spread of disease.
- Patients must not have other serious illness or medical conditions including, but not limited to the following: New York Heart Association (NYHA) Class II or greater congestive heart failure or unstable angina pectoris, uncontrolled hypertension or arrhythmias, active bacterial infections, or unstable diabetes mellitus.
- Patients must be disease-free of prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin.
Exclusion Criteria:
- Patients less than 18 years of age.
- CT evidence of metastatic disease.
- Pregnancy or considering pregnancy at the time of study entry.
- Breast feeding at the time of study entry.
- Prior therapy for pancreatic cancer including irradiation, chemotherapy, or immunotherapy.
- Receiving concurrent chemotherapy, immunotherapy, or radiotherapy that is not part of this protocol while participating in this study.
- Receiving concurrent treatment with any other investigational drug while on this protocol.
- Prior malignancy within 5 years, excluding squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix, lobular carcinoma in situ of the breast, or ductal carcinoma in situ of the breast.
- Non-malignant disease that would preclude protocol participation or follow-up.
- Myocardial infarction within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- Psychiatric disorders or conditions, that in the opinion of the investigator, would preclude the patient from providing truly informed consent.
- Presence of progressive sensory neuropathy or progressive hearing loss or tinnitus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CAPOXIRI Chemotherapy Regimen
Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI) The proposed chemotherapy regimen CAPOXIRI is:
|
Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that builds on the advancement associated with FOLFIRINOX chemotherapy in patients with metastatic disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary end point is the treatment adherence rate (TAR) which is the percentage of patients who complete 75% of the planned treatment (dose) for their diagnostic strata (resectable disease and borderline resectable/locally advanced disease)
Time Frame: 5 years
|
Adherence of subjects with treatment
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS),
Time Frame: 5 years
|
5 years
|
Progression Free Survival (PFS),
Time Frame: 5 years
|
5 years
|
Response Rate (RR),
Time Frame: 1 year
|
1 year
|
R0 resection rate for patients stratified as having resectable disease and borderline resectable disease.
Time Frame: 5 years
|
5 years
|
Disease-free survival (DFS; for those patients who are rendered disease-free by surgical resection),
Time Frame: 5 year
|
5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Oxaliplatin
- Irinotecan
Other Study ID Numbers
- CAPOXIRI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Pancreatic Adenocarcinoma
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Georgetown UniversityNational Cancer Institute (NCI); Mayo Clinic; Emory University; Indiana University and other collaboratorsTerminatedMetastatic Colorectal Cancer | Pancreatic Adenocarcinoma | Colorectal Adenocarcinoma | Metastatic Pancreatic CancerUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal AdenocarcinomaUnited States
-
Georgetown UniversityERYtech PharmaActive, not recruitingMetastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Ductal Adenocarcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal Adenocarcinoma | Primary Pancreatic Ductal AdenocarcinomaUnited States
-
Translational Genomics Research InstituteMerck Sharp & Dohme LLC; Stand Up To CancerCompletedPancreatic Cancer | Pancreas Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer | Advanced Pancreatic CancerUnited States
-
Scandion Oncology A/SAlcedis GmbHRecruitingMetastatic Pancreatic Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Inoperable Disease | Localized Pancreatic AdenocarcinomaDenmark, Germany
-
Mayo ClinicNovoCure Ltd.RecruitingPancreatic Adenocarcinoma | Pancreas Cancer | Metastatic Pancreatic Cancer | Metastatic AdenocarcinomaUnited States
-
Jean-Luc Van LaethemCelgene CorporationCompletedPancreatic Adenocarcinoma Resectable | Pancreatic Adenocarcinoma Metastatic | Pancreatic Adenocarcinoma Locally AdvancedBelgium
-
Colin D. Weekes, M.D., PhDActuate Therapeutics Inc.; Lustgarten FoundationRecruitingPancreatic Adenocarcinoma | Pancreatic Adenocarcinoma MetastaticUnited States
Clinical Trials on Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Sanofi; PfizerCompletedRecurrent Small Intestine Cancer | Small Intestine AdenocarcinomaUnited States
-
First Affiliated Hospital of Zhejiang UniversityUnknownUnresectable Metastatic Colorectal CancerChina
-
AHS Cancer Control AlbertaSanofiCompletedGastric Adenocarcinoma | Gastrointestinal NeoplasmCanada
-
ArQule, Inc. (a wholly owned subsidiary of Merck...Withdrawn
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Ludwig-Maximilians - University of MunichSanofi; Merck Sharp & Dohme LLC; Pfizer; Hoffmann-La RocheCompletedMetastatic Colorectal Cancer
-
National Cancer Centre, SingaporeNational Medical Research Council (NMRC), SingaporeCompletedPancreatic CancerSingapore
-
Zhejiang Cancer HospitalRecruitingRadiation | ToripalimabChina
-
Swiss Group for Clinical Cancer ResearchCompleted
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Chonnam National University... and other collaboratorsCompletedColorectal CancerKorea, Republic of