Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02243007
Other study ID # 14-218
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05209074 - Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma Phase 1
Not yet recruiting NCT05529940 - NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer) Phase 3
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Recruiting NCT05679050 - Phase II Study on Sequential AG and FOLFIRINOX as Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Withdrawn NCT01694589 - A Pilot Study of a Hedgehog Pathway Inhibitor (LDE-225) in Surgically Resectable Pancreas Cancer Phase 0
Active, not recruiting NCT03138720 - Pre-operative Treatment for Patients With Untreated Pancreatic Cancer Phase 2
Completed NCT01298011 - Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer Phase 2
Completed NCT06363084 - A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer
Recruiting NCT04810910 - Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy Phase 1
Completed NCT01992705 - Borderline Pancreas Study: FOLFIRINOX +SBRT Early Phase 1
Recruiting NCT05624918 - A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma Phase 2
Completed NCT02047513 - Neoadjuvant Plus Adjuvant or Only Adjuvant Nab- Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer Phase 2
Completed NCT02115022 - EUS vs. MDCT in Pancreatic Malignancy
Recruiting NCT03492671 - Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer Phase 2
Terminated NCT05546411 - A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer Phase 2
Not yet recruiting NCT06172036 - Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab Phase 2
Recruiting NCT05788744 - Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer N/A
Recruiting NCT04737551 - Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study
Recruiting NCT03822936 - Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma Phase 2
Completed NCT03435536 - Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer N/A