Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Pancreatic Adenocarcinoma Protocol

NCT01760252 | Terminated Phase 2

• 1 other identifier: CAPOXIRI
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  Adherence of subjects with treatment

  5 years

Secondary Outcomes (5)

• Overall survival (OS),

  5 years

• Progression Free Survival (PFS),

  5 years

• Response Rate (RR),

  1 year

• R0 resection rate for patients stratified as having resectable disease and borderline resectable disease.

  5 years

• Disease-free survival (DFS; for those patients who are rendered disease-free by surgical resection),

  5 year

Study Arms (1)

CAPOXIRI Chemotherapy Regimen

EXPERIMENTAL

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)

Interventions

Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI) DRUG

Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that builds on the advancement associated with FOLFIRINOX chemotherapy in patients with metastatic disease

CAPOXIRI Chemotherapy Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Medical Center: lead
• St. Luke's-Roosevelt Hospital Center: collaborator

Study Sites (3)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

St-Lukes Roosevelt Hospital Medical Center

New York, New York, 10018, United States

Location

Beth Israel Comprehensive Care Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Peter Kozuch, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: January 4, 2013
• Study Start: December 1, 2011
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

US (3)