Trial Outcomes & Findings for Chemoradiation in Locally Advanced Pancreatic Cancer (NCT NCT00262951)

Last Updated: 2017-12-28

Results Overview

Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 5 Years or Until Disease Progression

Results posted on

2017-12-28

Participant Flow

All patients participated in Part 1 of the study only.

Participant milestones

Participant milestones
Measure	Pancreatic Adenocarcinoma Patients Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
Overall Study STARTED	23
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Pancreatic Adenocarcinoma Patients Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
Overall Study Progressive disease/relapse	3
Overall Study Adverse Event	7
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Alternative treatment	3
Overall Study Off treatment for other disease	1

Baseline Characteristics

Chemoradiation in Locally Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pancreatic Adenocarcinoma Patients n=23 Participants Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 9.01 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Region of Enrollment United States	23 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 5 Years or Until Disease Progression

Outcome measures

Outcome measures
Measure	Pancreatic Adenocarcinoma Patients n=23 Participants Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
Number of Patients in Whom Tumor Was Resectable	7 Participants

SECONDARY outcome

Timeframe: Up to 5 Years or Date of Death, Whichever Occurred First

In all patients, measured from the date of the patient's registration in this study, until the date of the patient's death or date last known alive (if observation was censored).

Outcome measures

Outcome measures
Measure	Pancreatic Adenocarcinoma Patients n=23 Participants Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
Overall Survival	11.5 Months Interval 7.5 to 15.2

Adverse Events

Pancreatic Adenocarcinoma Patients

Serious events: 12 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pancreatic Adenocarcinoma Patients n=23 participants at risk Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
General disorders Fatigue (asthenia, lethargy, malaise)	4.3% 1/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Fever (in the absence of neutropenia)	8.7% 2/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Weight loss	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Anorexia	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Colitis	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Dehydration	21.7% 5/23 • Number of events 5 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Diarrhea	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Esophagitis	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Gastritis (including bile reflux)	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Gastrointestinal, other	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Nausea	13.0% 3/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Gallbladder perforation	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Vomiting	13.0% 3/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Melana/Gastrointestinal bleeding	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Upper Gastrointestinal hemorrhage	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Genitourinary hemorrhage	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Hemorrhage, other	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Infections and infestations Infection without neutropenia	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Infections and infestations Infection with normal absolute neutrophils	4.3% 1/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Syncope (fainting)	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Pain, other	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Renal and urinary disorders Renal/genitourinary, other	4.3% 1/23 • Number of events 1 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).

Other adverse events

Other adverse events
Measure	Pancreatic Adenocarcinoma Patients n=23 participants at risk Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m\^2/day for 38 days), weekly cisplatin 30 mg/m\^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m\^2 weekly \* 6, followed by 2 weeks of rest).
Blood and lymphatic system disorders Blood/Bone Marrow/Other	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Hemoglobin	47.8% 11/23 • Number of events 16 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Leucocytes/total white blood count	91.3% 21/23 • Number of events 99 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Neutrophils/granulocytes/absolute neutrophils/absolute granulocyte count	78.3% 18/23 • Number of events 58 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Blood and lymphatic system disorders Platelets	60.9% 14/23 • Number of events 32 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Fatigue/asthenia/lethargy/malaise	95.7% 22/23 • Number of events 46 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Fever in the absence of neutropenia	13.0% 3/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Insomnia	8.7% 2/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Nervous system disorders Rigors/chills	13.0% 3/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Weight loss	56.5% 13/23 • Number of events 32 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Skin and subcutaneous tissue disorders Dermatology/skin/other	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Skin and subcutaneous tissue disorders Dry skin	17.4% 4/23 • Number of events 8 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Skin and subcutaneous tissue disorders Hair loss/alopecia scalp or body	39.1% 9/23 • Number of events 12 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Skin and subcutaneous tissue disorders Nail changes	8.7% 2/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Skin and subcutaneous tissue disorders Rash/hand foot skin reaction	17.4% 4/23 • Number of events 9 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Anorexia	95.7% 22/23 • Number of events 53 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Constipation	34.8% 8/23 • Number of events 10 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Dehydration	87.0% 20/23 • Number of events 36 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Diarrhea	78.3% 18/23 • Number of events 33 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Mucositis/stomatitis/oral cavity	56.5% 13/23 • Number of events 33 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Nausea	91.3% 21/23 • Number of events 67 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Taste alteration/dysgeusia	47.8% 11/23 • Number of events 16 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Gastrointestinal disorders Vomiting	73.9% 17/23 • Number of events 39 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Respiratory, thoracic and mediastinal disorders Hemorrhage/pulmonary/upper respiratory	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders Albumin serum low/hypoalbulinemia	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders Alkaline phosphatase	17.4% 4/23 • Number of events 5 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders ALT/SGPT/serum glutammic pyruvic transaminase	8.7% 2/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders AST/SGOT/serum glutamic oxaloacetic transaminase	8.7% 2/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders Calcium/serum low hypocalcemia	78.3% 18/23 • Number of events 30 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders Glucose serum high hyperglycemia	17.4% 4/23 • Number of events 12 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders Magnesium serum low hypomagnesemia	52.2% 12/23 • Number of events 21 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Metabolism and nutrition disorders Potassium serum low/hypokalemia	26.1% 6/23 • Number of events 8 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Nervous system disorders Mood alteration/depression	13.0% 3/23 • Number of events 3 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Nervous system disorders Neuropathyy sensory	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Pain/abdomen nonspecific	52.2% 12/23 • Number of events 21 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Pain back	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Pain/head/headache	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Pain/throat/pharynx/larynx	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
General disorders Pain/other	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Respiratory, thoracic and mediastinal disorders Cough	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory	8.7% 2/23 • Number of events 2 • Adverse events were assessed during study treatment and for 1 month following study treatment (for up to 10 months).

Additional Information

Edward Greeno, M.D.

University of Minnesota, Masonic Cancer Center

Phone: 612-626-6418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place