Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

NCT02243007 | Terminated Phase 2 Results DMC

• 1 other identifier: 14-218
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.

Conditions

Resectable Pancreatic Cancer; Pancreatic Ductal Carcinoma

Keywords

Resectable pancreatic cancer; Pancreatic Ductal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Survival Rate at 18 Month

  Number of participants surviving after 18 months of study follow-up

  18 Month

Secondary Outcomes (8)

• Pathologic Complete Response Rate (pCR).

  18 Months

• Overall Survival Rate

  Baseline, 5 Years

• Number of Participants With Serious and Non-Serious Adverse Events

  Baseline, 28 Days

• Surgical Morbidity Rate

  within 30 days of surgery

• 30-day Post-operative Mortality Rate

  30 Days

Study Arms (2)

Folfirinox-ARM A

EXPERIMENTAL

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel * Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days. * After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine. * Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Drug: FOLFIRINOX; Radiation: Radiation therapy; Drug: Capecitabine

Gemcitabine/nab-Paclitaxel- Arm B

EXPERIMENTAL

* Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel). * Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period. * After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine * Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Drug: Gemcitabine/nab-Paclitaxel; Radiation: Radiation therapy; Drug: Capecitabine

Interventions

FOLFIRINOX DRUG

Folfirinox-ARM A

Gemcitabine/nab-Paclitaxel DRUG

Gemcitabine/nab-Paclitaxel- Arm B

Radiation therapy RADIATION

Folfirinox-ARM A; Gemcitabine/nab-Paclitaxel- Arm B

Capecitabine DRUG

Also known as: Xeloda

Folfirinox-ARM A; Gemcitabine/nab-Paclitaxel- Arm B

Eligibility Criteria

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

You may qualify if:

• Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to study entry.
• No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross peritoneal or distant metastases by laparoscopy.
• Patients must be 18 years old or older. There will be no upper age restriction.
• ECOG Performance Status of 0 or 1 are eligible.
• Life expectancy of greater than 3 months.
• Lab Values:
• ANC ≥ 1500 cells/mm3
• Platelet count at least 100,000 cells/mm3.
• AST and ALT ≤2.5 x upper limit of normal
• Total Bilirubin ≤ 5 x upper limit of normal if patient is s/p biliary stenting AND decreasing at least two time points after stenting.
• Total Bilirubin ≤ 1.5 x upper limit of normal if no biliary stenting was done
• Serum Creatinine ≤1.5mg/dl OR
• Creatinine Clearance greater than or equal to 30ml/min (as estimated by Cockroft Gault Equation) (140 - age \[yrs\]) (body wt \[kg\])
• Creatinine clearance for males = ------------ (72) (serum creatinine \[mg/dL\])
• Creatinine clearance for females = 0.85 x male value

You may not qualify if:

• Patients who fulfill any of the following criteria will be excluded:
• The presence of metastatic disease on imaging or laparoscopy.
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever.
• Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
• Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
• Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.
• Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake.
• Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Interventions

folfirinox; Radiotherapy; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: David P. Ryan, MD
• Organization: Massachusetts General Hospital

dpryan@mgh.harvard.edu

6177240245

Study Officials

• David Ryan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)