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

Resectable Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243007
• Other study ID #: 14-218
• Status: Recruiting
• Phase: Phase 2
• First received: September 15, 2014
• Last updated: July 2, 2015
• Start date: September 2014
• Est. completion date: March 2022

Study information

• Verified date: July 2015
• Source: Massachusetts General Hospital
• Contact: David Ryan, MD
• Phone: 617-724-4000
• Email: DPRYAN[@]PARTNERS.ORG
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

• Treatment will be administered on an outpatient basis.

• Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).

• After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .

• Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 2022
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• The effects of radiation on the developing human fetus are known to be teratogenic. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment plus 30 days from the last date of study drug administration. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Ductal
• Carcinoma, Pancreatic Ductal
• Pancreatic Ductal Carcinoma
• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

Drug:
• FOLFIRINOX

• Gemcitabine/nab-Paclitaxel

Radiation:
• Radiation therapy

Drug:
• Capecitabine

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate at 18 Month		18 Month	Yes
Secondary	Pathologic complete response rate (pCR).		18 Months	No
Secondary	Overall Survival Rate	Kaplan-Meier	Baseline, 5 Years	Yes
Secondary	Number of Participants with Serious and Non-Serious Adverse Events		Baseline, 28 Days	Yes
Secondary	Surgical morbidity rate		within 30 days	Yes
Secondary	30-day post-operative mortality rate		30 Days	Yes
Secondary	Correlation of biomarkers with PFS		2 Years	No
Secondary	Rate of pathologic downstaging		2 Years	No
Secondary	Local Control Rate		2 Years	No