Trial Outcomes & Findings for Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer (NCT NCT00761345)
NCT ID: NCT00761345
Last Updated: 2017-03-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
weekly physician and nurse assessment and in between as needed until 30 days after treatment termination
Results posted on
2017-03-07
Participant Flow
Participant milestones
| Measure |
Radiotherapy and Chemotherapy
gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Radiotherapy and Chemotherapy
n=27 Participants
gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weekly physician and nurse assessment and in between as needed until 30 days after treatment terminationPopulation: 27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.
Outcome measures
| Measure |
Radiotherapy and Chemotherapy
n=27 Participants
gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
|
|---|---|
|
To Determine the Dose Limiting Toxicities
|
27 participants
|
SECONDARY outcome
Timeframe: Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survivalOutcome measures
Outcome data not reported
Adverse Events
Radiotherapy and Chemotherapy
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiotherapy and Chemotherapy
n=27 participants at risk
gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Vascular disorders
DVT
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Gastrointestinal disorders
GI bleed
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.8%
4/27 • Number of events 4 • 3.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Hepatobiliary disorders
Biliary obstruction
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Gastrointestinal disorders
Perforated viscous
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
14.8%
4/27 • Number of events 4 • 3.5 years
|
Other adverse events
| Measure |
Radiotherapy and Chemotherapy
n=27 participants at risk
gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle
gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle
low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
hemoglobin
|
92.6%
25/27 • Number of events 120 • 3.5 years
|
|
Blood and lymphatic system disorders
ANC
|
51.9%
14/27 • Number of events 41 • 3.5 years
|
|
Blood and lymphatic system disorders
WBC
|
81.5%
22/27 • Number of events 84 • 3.5 years
|
|
Blood and lymphatic system disorders
Platelets
|
70.4%
19/27 • Number of events 68 • 3.5 years
|
|
General disorders
Edema
|
22.2%
6/27 • Number of events 15 • 3.5 years
|
|
Vascular disorders
DVT
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 3 • 3.5 years
|
|
General disorders
Fever
|
22.2%
6/27 • Number of events 13 • 3.5 years
|
|
General disorders
Fatigue
|
96.3%
26/27 • Number of events 107 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
11.1%
3/27 • Number of events 5 • 3.5 years
|
|
Eye disorders
watery eyes
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Number of events 2 • 3.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
18/27 • Number of events 61 • 3.5 years
|
|
Skin and subcutaneous tissue disorders
Dry desquamation
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Skin and subcutaneous tissue disorders
Dry cracked skin
|
3.7%
1/27 • Number of events 2 • 3.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.7%
1/27 • Number of events 2 • 3.5 years
|
|
Hepatobiliary disorders
Jaundice
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Vascular disorders
Hemorrhage
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Gastrointestinal disorders
Ascites
|
18.5%
5/27 • Number of events 18 • 3.5 years
|
|
Gastrointestinal disorders
GI bleed
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Gastrointestinal disorders
Nausea
|
74.1%
20/27 • Number of events 53 • 3.5 years
|
|
Gastrointestinal disorders
Vomiting
|
48.1%
13/27 • Number of events 35 • 3.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
14.8%
4/27 • Number of events 6 • 3.5 years
|
|
Gastrointestinal disorders
Dyspesia
|
18.5%
5/27 • Number of events 10 • 3.5 years
|
|
Gastrointestinal disorders
Heartburn
|
11.1%
3/27 • Number of events 12 • 3.5 years
|
|
Gastrointestinal disorders
Constipation
|
37.0%
10/27 • Number of events 27 • 3.5 years
|
|
Gastrointestinal disorders
Ileus/bowel obstruction
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Gastrointestinal disorders
Bowel perforation
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
81.5%
22/27 • Number of events 65 • 3.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
29.6%
8/27 • Number of events 14 • 3.5 years
|
|
Gastrointestinal disorders
Mucositis
|
3.7%
1/27 • Number of events 2 • 3.5 years
|
|
Gastrointestinal disorders
Dysgeusia
|
7.4%
2/27 • Number of events 6 • 3.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
77.8%
21/27 • Number of events 69 • 3.5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.7%
1/27 • Number of events 3 • 3.5 years
|
|
Metabolism and nutrition disorders
Weight loss
|
51.9%
14/27 • Number of events 43 • 3.5 years
|
|
Psychiatric disorders
Insomnia
|
25.9%
7/27 • Number of events 15 • 3.5 years
|
|
Psychiatric disorders
Depression
|
37.0%
10/27 • Number of events 32 • 3.5 years
|
|
Nervous system disorders
Neuropathy, sensory
|
3.7%
1/27 • Number of events 5 • 3.5 years
|
|
Nervous system disorders
Tremor
|
7.4%
2/27 • Number of events 8 • 3.5 years
|
|
General disorders
Pain
|
59.3%
16/27 • Number of events 47 • 3.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
44.4%
12/27 • Number of events 32 • 3.5 years
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia/Arthralgia
|
11.1%
3/27 • Number of events 6 • 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.6%
8/27 • Number of events 13 • 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.4%
2/27 • Number of events 3 • 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.0%
10/27 • Number of events 19 • 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Investigations
Hyperbilirubinemia
|
18.5%
5/27 • Number of events 6 • 3.5 years
|
|
Investigations
Alkaline phosphatase
|
55.6%
15/27 • Number of events 51 • 3.5 years
|
|
Investigations
Creatinine
|
25.9%
7/27 • Number of events 10 • 3.5 years
|
|
Investigations
SGOT/AST
|
44.4%
12/27 • Number of events 18 • 3.5 years
|
|
Investigations
SGPT/ALT
|
25.9%
7/27 • Number of events 10 • 3.5 years
|
|
Infections and infestations
Infection, without neurtropenia
|
22.2%
6/27 • Number of events 10 • 3.5 years
|
|
Infections and infestations
Infection, with neutropenia
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Investigations
Hyperglycemia
|
66.7%
18/27 • Number of events 60 • 3.5 years
|
|
Investigations
Hypoglycemia
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Investigations
Hypoalbuminemia
|
85.2%
23/27 • Number of events 94 • 3.5 years
|
|
Investigations
Hypokalemia
|
59.3%
16/27 • Number of events 38 • 3.5 years
|
|
Investigations
Hyponatremia
|
59.3%
16/27 • Number of events 35 • 3.5 years
|
|
Investigations
Hypocalcemia
|
29.6%
8/27 • Number of events 17 • 3.5 years
|
|
Investigations
Lymphopenia
|
25.9%
7/27 • Number of events 19 • 3.5 years
|
|
Investigations
Hypomagnesemia
|
22.2%
6/27 • Number of events 9 • 3.5 years
|
|
Investigations
Low bicarbonate
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Renal and urinary disorders
Dysuria
|
3.7%
1/27 • Number of events 1 • 3.5 years
|
|
Skin and subcutaneous tissue disorders
Radiation dermititis
|
3.7%
1/27 • Number of events 3 • 3.5 years
|
|
Cardiac disorders
Tachycardia
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Vascular disorders
Hypotension
|
7.4%
2/27 • Number of events 2 • 3.5 years
|
|
Nervous system disorders
Dizziness
|
11.1%
3/27 • Number of events 3 • 3.5 years
|
|
General disorders
Chills
|
3.7%
1/27 • Number of events 2 • 3.5 years
|
|
General disorders
Sweats
|
3.7%
1/27 • Number of events 2 • 3.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place