Trial Outcomes & Findings for Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients (NCT NCT00966277)
NCT ID: NCT00966277
Last Updated: 2016-12-12
Results Overview
Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
16 weeks of treatment
Results posted on
2016-12-12
Participant Flow
Recruitment period: April 06, 2010 to August 23, 2012. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
Of the 87 participants enrolled on the study, only 75 were randomized. Twelve enrolling participants were screen failures or withdrew before randomization thus were excluded before assignments to groups.
Participant milestones
| Measure |
Group 1: Dalteparin
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
|
Group 2: Control
No Dalteparin study drug (primary prophylaxis).
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Group 1: Dalteparin
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
|
Group 2: Control
No Dalteparin study drug (primary prophylaxis).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Ineligible
|
1
|
3
|
|
Overall Study
Treatment Plan Changed
|
0
|
1
|
Baseline Characteristics
Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
Baseline characteristics by cohort
| Measure |
Group 1: Dalteparin
n=38 Participants
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
|
Group 2: Control
n=37 Participants
No Dalteparin study drug.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=93 Participants
|
64 years
n=4 Participants
|
61.5 years
n=27 Participants
|
|
Age, Customized
<60
|
21 years
n=93 Participants
|
10 years
n=4 Participants
|
31 years
n=27 Participants
|
|
Age, Customized
>=60
|
17 years
n=93 Participants
|
27 years
n=4 Participants
|
44 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Causacian
|
31 participants
n=93 Participants
|
31 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown or Unreported
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
37 participants
n=4 Participants
|
75 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeks of treatmentVenous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.
Outcome measures
| Measure |
Group 1: Dalteparin
n=38 Participants
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
|
Group 2: Control
n=37 Participants
No Dalteparin study drug.
|
|---|---|---|
|
Number of Participants With Venous Thromboembolic Events (VTE)
|
2 participants
|
9 participants
|
Adverse Events
Group 1: Dalteparin
Serious events: 34 serious events
Other events: 34 other events
Deaths: 0 deaths
Group 2: Control
Serious events: 33 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Dalteparin
n=34 participants at risk
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
|
Group 2: Control
n=33 participants at risk
No Dalteparin study drug.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
44.1%
15/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
21.2%
7/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
47.1%
16/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
27.3%
9/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
35.3%
12/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
21.2%
7/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
58.8%
20/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
45.5%
15/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
Other adverse events
| Measure |
Group 1: Dalteparin
n=34 participants at risk
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
|
Group 2: Control
n=33 participants at risk
No Dalteparin study drug.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
18.2%
6/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Psychiatric disorders
Anxiety
|
11.8%
4/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
24.2%
8/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.8%
3/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
24.2%
8/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Injury, poisoning and procedural complications
Bruising/minor bleeding
|
23.5%
8/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
6.1%
2/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
24.2%
8/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (Other)
|
5.9%
2/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
21.2%
7/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
6/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
27.3%
9/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Injury, poisoning and procedural complications
Bruising/Bleeding
|
0.00%
0/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
3.0%
1/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
18.2%
6/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
6/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
30.3%
10/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Eye disorders
Ocular/Visual (Other)
|
5.9%
2/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
24.2%
8/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
12.1%
4/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (Other)
|
0.00%
0/34 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
15.2%
5/33 • Follow-up/observation for all adverse events will be through Day 28 following the last dose of study drug or until resolution of any toxicity related to the study drug at the end of treatment.
|
Additional Information
Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place