Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

NCT ID: NCT02626520

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-11
• Study Completion Date: 2017-09-14

Brief Summary

Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Detailed Description

Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).

All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.

All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 & 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.

After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.

Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.

Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Conditions

Ductal Adenocarcinoma of Pancreas; Adenocarcinoma of Ampulla

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resectable, Low Risk

Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.

Group Type: EXPERIMENTAL

Gemcitabine and nanoparticle albumin bound paclitaxel

Intervention Type: DRUG

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Definitive resection

Intervention Type: PROCEDURE

Definitive surgical resection of primary tumor

Locally Advanced

Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Group Type: EXPERIMENTAL

Gemcitabine and nanoparticle albumin bound paclitaxel

Intervention Type: DRUG

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

5-fluorouracil and irinotecan

Intervention Type: DRUG

FOLFIRI.3 given every 14 days x 4 cycles

Preoperative chemoradiation

Intervention Type: RADIATION

Pre-operative chemoradiation to 40 Gy in 20 fractions

Definitive resection

Intervention Type: PROCEDURE

Definitive surgical resection of primary tumor

Interventions

Gemcitabine and nanoparticle albumin bound paclitaxel

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Intervention Type: DRUG

5-fluorouracil and irinotecan

FOLFIRI.3 given every 14 days x 4 cycles

Intervention Type: DRUG

Preoperative chemoradiation

Pre-operative chemoradiation to 40 Gy in 20 fractions

Intervention Type: RADIATION

Definitive resection

Definitive surgical resection of primary tumor

Intervention Type: PROCEDURE

Other Intervention Names

Gem/Abraxane, Gemcitabine/nab-paclitaxel; FOLFIRI.3, FOLFIRI-3; pancreaticoduodenectomy, Whipple procedure

Eligibility Criteria

Inclusion Criteria

• Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
• Fitness for chemotherapy in judgement of treating physician
• Bilirubin < 4 (any means of biliary drainage acceptable)

Exclusion Criteria

• Medical or mental illness precluding provision of informed consent
• Pregnancy
• Active infection for which neutropenia would pose high risk of mortality

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essentia Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kebbekus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Essentia Health Cancer Center

Locations

Essentia Health Cancer Center

Duluth, Minnesota, United States

Countries

United States

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

PANC-1

Identifier Type: -

Identifier Source: org_study_id