Trial Outcomes & Findings for Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer (NCT NCT00310076)
NCT ID: NCT00310076
Last Updated: 2018-08-23
Results Overview
Time to progression after surgery was recorded.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
9 hours
Results posted on
2018-08-23
Participant Flow
Participant milestones
| Measure |
Chemo Therapy Followed by Thalidomide
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
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|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer
Baseline characteristics by cohort
| Measure |
Chemo Therapy Followed by Thalidomide
n=26 Participants
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 hoursTime to progression after surgery was recorded.
Outcome measures
| Measure |
Chemo Therapy Followed by Thalidomide
n=26 Participants
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
|
|---|---|
|
Time to Progression
|
0.775 years
Interval 0.42 to 3.38
|
SECONDARY outcome
Timeframe: 60 months after treatmentOutcome measures
| Measure |
Chemo Therapy Followed by Thalidomide
n=26 Participants
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
|
|---|---|
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Progression Free Survival
|
0.775 years
Interval 0.42 to 3.38
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SECONDARY outcome
Timeframe: up to 60 monthsAdverse events with Common Toxicity Criteria grades of 3 and 4 are reported
Outcome measures
| Measure |
Chemo Therapy Followed by Thalidomide
n=26 Participants
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
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|---|---|
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Number of Events of Toxicity Graded 3 and 4
Grade 3
|
17 number of events
|
|
Number of Events of Toxicity Graded 3 and 4
Grade 4
|
4 number of events
|
Adverse Events
Chemo Therapy Followed by Thalidomide
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemo Therapy Followed by Thalidomide
n=27 participants at risk
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
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|---|---|
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Cardiac disorders
Cardiac Dysrhythmias
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Cardiac disorders
Cardiovascular/General-other
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Gastrointestinal disorders
Constipation
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Investigations
Creatinine
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
General disorders
Dysphagia, esophagitis, odynophagia
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
General disorders
Fatigue
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Gastrointestinal disorders
other gastrointestinal
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Investigations
Hemoglobin
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Blood and lymphatic system disorders
Hemorrhage
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
General disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Investigations
Hypokalemia
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Investigations
Hypomagnesemia
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
General disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
General disorders
Hypoxia
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Infections and infestations
Infection with unknown ANC
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
Psychiatric disorders
Neuro-mood
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Psychiatric disorders
Neuro-motor
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Nervous system disorders
Neurosensory
|
18.5%
5/27 • Number of events 5 • up to 60 months
|
|
Nervous system disorders
Pain-other
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Cardiac disorders
Thrombosis/Embolism
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Renal and urinary disorders
Ureteral Obstruction
|
3.7%
1/27 • Number of events 1 • up to 60 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
General disorders
Weight Gain
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
Other adverse events
| Measure |
Chemo Therapy Followed by Thalidomide
n=27 participants at risk
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
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|---|---|
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Investigations
Leukocytes
|
37.0%
10/27 • Number of events 10 • up to 60 months
|
|
General disorders
Anorexia
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
Investigations
Alk Phos
|
29.6%
8/27 • Number of events 8 • up to 60 months
|
|
General disorders
Alopecia
|
18.5%
5/27 • Number of events 5 • up to 60 months
|
|
Metabolism and nutrition disorders
Edema
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
Investigations
Absolute Neutrophil Count
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
General disorders
Dizziness/vertigo
|
14.8%
4/27 • Number of events 4 • up to 60 months
|
|
General disorders
Insomnia
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Nervous system disorders
Neurologic Other
|
33.3%
9/27 • Number of events 9 • up to 60 months
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
25.9%
7/27 • Number of events 7 • up to 60 months
|
|
General disorders
Weight Loss
|
14.8%
4/27 • Number of events 4 • up to 60 months
|
|
Investigations
Hyperglycemia
|
51.9%
14/27 • Number of events 14 • up to 60 months
|
|
Investigations
Hypoglycemia
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Investigations
Hypocalcemia
|
29.6%
8/27 • Number of events 8 • up to 60 months
|
|
Investigations
Hyponatremia
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Investigations
Coagulation Other
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
General disorders
Hot flashes/flushes
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Endocrine disorders
Endocrine Other
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
Investigations
Hypoalbuminemia
|
14.8%
4/27 • Number of events 4 • up to 60 months
|
|
Investigations
Serum glutamic pyruvic transaminase
|
25.9%
7/27 • Number of events 7 • up to 60 months
|
|
General disorders
Somnolence
|
18.5%
5/27 • Number of events 5 • up to 60 months
|
|
Investigations
Serum glutamic oxaloacetic transaminase
|
18.5%
5/27 • Number of events 5 • up to 60 months
|
|
Investigations
Hyperkalemia
|
14.8%
4/27 • Number of events 4 • up to 60 months
|
|
Investigations
Hypernatremia
|
11.1%
3/27 • Number of events 3 • up to 60 months
|
|
Investigations
Fever in the absence of neutropenia
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Infections and infestations
Infection-Other
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
|
Ear and labyrinth disorders
Auditory/Ear-Other
|
7.4%
2/27 • Number of events 2 • up to 60 months
|
Additional Information
Greg Russell, MS
Comprehensive Cancer Center of Wake Forest University
Phone: 336-716-5449
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place