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

Adenocarcinoma of Ampulla Clinical Trial

Official title:

Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02626520
• Other study ID #: PANC-1
• Status: Terminated
• Phase: Phase 2
• Start date: May 11, 2016
• Est. completion date: September 14, 2017

Study information

• Verified date: October 2018
• Source: Essentia Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 14, 2017
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Ampulla
• Ductal Adenocarcinoma of Pancreas

Intervention

Drug:
• Gemcitabine and nanoparticle albumin bound paclitaxel
Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles
• 5-fluorouracil and irinotecan
FOLFIRI.3 given every 14 days x 4 cycles

Radiation:
• Preoperative chemoradiation
Pre-operative chemoradiation to 40 Gy in 20 fractions

Procedure:
• Definitive resection
Definitive surgical resection of primary tumor

Locations

Country	Name	City	State
United States	Essentia Health Cancer Center	Duluth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Essentia Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Free Survival	Percentage of patients alive and free of detectable disease 1 yr from start of treatment	1 yr form onset of treatment
Secondary	R-0 Rate	Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)	Time of surgery
Secondary	Overall Survival	Time to death from any cause measured from start of treatment	Up to 3 years from registration