Trial Outcomes & Findings for Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer (NCT NCT00305760)
NCT ID: NCT00305760
Last Updated: 2020-02-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
7 months
Results posted on
2020-02-19
Participant Flow
Participant milestones
| Measure |
Group 1: Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Group 1
n=60 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 monthsOutcome measures
| Measure |
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
n=60 Participants
|
|---|---|
|
Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population
|
2 Adverse Events
|
Adverse Events
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Serious events: 12 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
n=60 participants at risk
Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.
|
|---|---|
|
General disorders
Infusion reaction, erbitux
|
20.0%
12/60
|
Other adverse events
| Measure |
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
n=60 participants at risk
Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
5/60
|
|
Cardiac disorders
Hypotension
|
5.0%
3/60
|
|
Musculoskeletal and connective tissue disorders
Arthragia
|
10.0%
6/60
|
|
General disorders
Chills
|
10.0%
6/60
|
|
General disorders
Fatigue
|
15.0%
9/60
|
|
General disorders
Fever
|
28.3%
17/60
|
|
General disorders
Flu like symptoms
|
16.7%
10/60
|
|
Skin and subcutaneous tissue disorders
Blisters
|
5.0%
3/60
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
3/60
|
|
Skin and subcutaneous tissue disorders
Erythema, vaccine site
|
93.3%
56/60
|
|
Skin and subcutaneous tissue disorders
Induration, vaccine site
|
96.7%
58/60
|
|
Skin and subcutaneous tissue disorders
Pruritis, vaccine site
|
78.3%
47/60
|
|
Skin and subcutaneous tissue disorders
Tenderness, vaccine site
|
81.7%
49/60
|
|
Skin and subcutaneous tissue disorders
Pruritis, generalized
|
11.7%
7/60
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.3%
35/60
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
3/60
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
5/60
|
|
Gastrointestinal disorders
Nausea
|
20.0%
12/60
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60
|
|
Nervous system disorders
Headache
|
43.3%
26/60
|
Additional Information
Dr. Daniel Laheru
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place