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Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Pancreatic Adenocarcinoma Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Beth Israel Medical Center
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01760252
First received: May 18, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) may be better than other combinations used to treat earlier stage pancreatic cancer patients with resectable (able to be cut out), borderline resectable, and locally advanced pancreatic adenocarcinoma. For subjects who can not obtain Capecitabine can be treated with 5-Fluorouracil (5-FU) along with Oxaliplatin and Irinotecan. Though all of the drugs in this study have been approved by the FDA, their combination is investigational. The purpose of this study is to evaluate the effects of CAPOXIRI (good and bad) on you and your cancer.


Condition Intervention Phase
Metastatic Pancreatic Adenocarcinoma
Drug: Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Adherence of subjects with treatment


Secondary Outcome Measures:
  • Overall survival (OS), [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS), [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Response Rate (RR), [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • R0 resection rate for patients stratified as having resectable disease and borderline resectable disease. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS; for those patients who are rendered disease-free by surgical resection), [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAPOXIRI Chemotherapy Regimen

Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)

The proposed chemotherapy regimen CAPOXIRI is:

  • Capecitabine 1000mg/m2 p.o. bid on days 1-7
  • Oxaliplatin 85mg/m2 intravenously (IV) on day 1
  • Irinotecan 150mg/m2 IV on day 1
Drug: Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)
Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that builds on the advancement associated with FOLFIRINOX chemotherapy in patients with metastatic disease

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is clinically staged as resectable, borderline resectable, or locally advanced as determined by CT criteria.
  2. Age ≥ 18 years old.
  3. An Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 (Appendix B).
  4. Patients must give written informed consent as per institutional and federal regulatory requirements.
  5. An interval between initial diagnosis and consent of ≤ 42 days.
  6. An interval between consent and initiating protocol-directed therapy of ≤ 14 days.
  7. CT scan to stratify as resectable versus borderline resectable/locally advanced status within 28 days of initiating protocol-directed therapy.
  8. A general level of health that would indicate a life expectancy of 5 years, excluding the patient's cancer diagnosis.
  9. No prior chemotherapy, immunotherapy or radiotherapy for pancreatic adenocarcinoma.
  10. Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Appendix C).
  11. Absolute granulocyte count of ≥ 1,500/mm3 and a platelet count of ≥ 100,000/mm3.
  12. 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.
  13. Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry.
  14. There must be no extra-pancreatic spread of disease.
  15. 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.
  16. 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:

  1. Patients less than 18 years of age.
  2. CT evidence of metastatic disease.
  3. Pregnancy or considering pregnancy at the time of study entry.
  4. Breast feeding at the time of study entry.
  5. Prior therapy for pancreatic cancer including irradiation, chemotherapy, or immunotherapy.
  6. Receiving concurrent chemotherapy, immunotherapy, or radiotherapy that is not part of this protocol while participating in this study.
  7. Receiving concurrent treatment with any other investigational drug while on this protocol.
  8. 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.
  9. Non-malignant disease that would preclude protocol participation or follow-up.
  10. 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.
  11. Psychiatric disorders or conditions, that in the opinion of the investigator, would preclude the patient from providing truly informed consent.
  12. Presence of progressive sensory neuropathy or progressive hearing loss or tinnitus.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760252

Contacts
Contact: Zhijun Du, MD 212-844-6647 zdu@chpnet.org

Locations
United States, New York
Beth Israel Comprehensive Care Center Recruiting
New York, New York, United States, 10025
Contact: Tiffany Xing, MD    212-367-0190    txing@chpnet.org   
Contact: Damien Francois, CCRC    212-367-1740    dfrancoi@chpnet.org   
Sub-Investigator: Michael Wayne, MD         
Principal Investigator: walter Choi, MD         
Sub-Investigator: John Rescigno, MD         
Sub-Investigator: ZuJun Li, MD         
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: Rotsen Rocha, MS    212-844-8133    rrocha@chpnet.org   
Contact: Damien Francois, CCRC    212-367-1740    dfrancoi@chpnet.org   
Sub-Investigator: Michael Wayne, MD         
Principal Investigator: walter Choi, MD         
Sub-Investigator: John Rescigno, MD         
Sub-Investigator: ZuJun Li, MD         
St-Lukes Roosevelt Hospital Medical Center Recruiting
New York, New York, United States, 10018
Contact: Takhir Mirzoyev, MD    212-523-7289      
Sub-Investigator: Paul Gliedman, MD         
Sponsors and Collaborators
Beth Israel Medical Center
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Peter Kozuch, MD Beth Israel Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01760252     History of Changes
Other Study ID Numbers: CAPOXIRI
Study First Received: May 18, 2012
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:
Pancreatic Cancer

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Capecitabine
Irinotecan
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014