Trial Outcomes & Findings for A Trial of Chemo & Radiation Therapy for Pancreatic Cancer (NCT NCT00424827)

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

1-year

Results posted on

2017-06-01

Participant Flow

Between 2006 and 2011, twenty-six patients were screened and eleven of them were enrolled in the study. Most common reasons for screen failures were having resectable disease, metastatic disease or co-morbidity. Ten patients were able to tolerate and complete cycle 1 of chemoradiotherapy.

Most common reasons for screen failures were having resectable disease, metastatic disease or co-morbidity. A minority of patients present with localized disease. Surgical resection only hope for long-term survival. Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases.

Participant milestones

Participant milestones
Measure	Single Arm This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma. Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma. Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Overall Study Adverse Event	1

Baseline Characteristics

A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	This Was a Prospective, Single Arm, Open Label Pilot Phase II n=11 Participants "A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil, and Radiation Therapy in Locally Advanced Nonmetastatic Pancreatic Adenocarcinoma" This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma. Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases. The purpose of this study is to evaluate the efficacy and safety of cetuximab in combination with gemcitabine and 5-FU along with radiation therapy in locally advanced non-resectable, pancreatic adenocarcinoma, using progression free survival as the primary end point.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	66 years n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: 1-year

Population: Must have histologic confirmation of pancreatic adenocarcinoma with measurable disease per RECIST criteria, with locoregional disease not amenable to surgery were enrolled: based on(1) size of the tumor, 5cm; (2) lymph nodes; (3) vascular involvement or impingement on major vessels; and (4) invasion into the adjacent structures.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Gemcitabine/Fluorouracil With External Beam Radiation: n=11 Participants Progression-free survival
Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.	7.17 months Interval 2.53 to 18.43

SECONDARY outcome

Timeframe: 1-year

Population: Biomarker response (CA19-9) as defined by at least a 20% decrease from baseline

20% decrease in biomarker (CA19-9) from baseline

Outcome measures

Outcome measures
Measure	Gemcitabine/Fluorouracil With External Beam Radiation: n=10 Participants Progression-free survival
Biomarker Response to Chemoradiation Therapy	7 participants

SECONDARY outcome

Timeframe: 1-Year

Population: 4 subjects underwent resection after treatment

Outcome measures

Outcome measures
Measure	Gemcitabine/Fluorouracil With External Beam Radiation: n=11 Participants Progression-free survival
Resection Rate	4 participants

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Gemcitabine/Fluorouracil With External Beam Radiation: n=11 Participants Progression-free survival
Overall Survival	17 months Interval 7.1 to 27.6

SECONDARY outcome

Timeframe: 1-Year

Outcome measures

Outcome measures
Measure	Gemcitabine/Fluorouracil With External Beam Radiation: n=11 Participants Progression-free survival
Toxicity Associated With This Regimen.	2 participants

Adverse Events

Gemcitabine/Fluorouracil With External Beam Radiation

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine/Fluorouracil With External Beam Radiation n=11 participants at risk antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Cardiac disorders Cardiac Dysrhythmia	9.1% 1/11 • Number of events 1 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Gastrointestinal disorders nausea	9.1% 1/11 • Number of events 1 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Gastrointestinal disorders radiation-related duodenitis, biliary obstruction	9.1% 1/11 • Number of events 1 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Gastrointestinal disorders Dehydration, biliary obstruction	9.1% 1/11 • Number of events 1 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years

Other adverse events

Other adverse events
Measure	Gemcitabine/Fluorouracil With External Beam Radiation n=11 participants at risk antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Blood and lymphatic system disorders Lymphopenia	90.9% 10/11 • Number of events 17 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Gastrointestinal disorders Diarrhea	72.7% 8/11 • Number of events 17 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Blood and lymphatic system disorders Hypoalbuminemia	72.7% 8/11 • Number of events 10 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Blood and lymphatic system disorders hypocalcemia	72.7% 8/11 • Number of events 10 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years
Gastrointestinal disorders nausea	63.6% 7/11 • Number of events 10 • 3 years Subjects were evaluated every 3 months for 1 year, then every 6 months for an additional 2 years

Additional Information

Bilal Piperdi, MD

Universiy of MA Medical School

Phone: 508-426-0442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place