Trial Outcomes & Findings for Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer (NCT NCT00019747)
NCT ID: NCT00019747
Last Updated: 2015-10-28
Results Overview
Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
62 months
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
Arm 1 - Thalidomide Once Daily
Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
|
Arm 2 - Placebo Once Daily
Patients receive oral placebo once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
16
|
|
Overall Study
COMPLETED
|
23
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 - Thalidomide Once Daily
n=23 Participants
Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
|
Arm 2 - Placebo Once Daily
n=16 Participants
Patients receive oral placebo once daily.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
64.89 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
71.19 years
STANDARD_DEVIATION 11.76 • n=7 Participants
|
67.47 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 62 monthsPopulation: The analysis was not done because there were not enough subjects to do any of the statistical analyses.
Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 - Thalidomide Once Daily
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 2 - Placebo Once Daily
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - Thalidomide Once Daily
n=23 participants at risk
Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
|
Arm 2 - Placebo Once Daily
n=16 participants at risk
Patients receive oral placebo once daily.
|
|---|---|---|
|
Hepatobiliary disorders
AST
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Vascular disorders
CVA/TIA
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Renal and urinary disorders
Urethral obstruction (non-FDA reportable)
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Abdominal pain
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Possible pulmonary embolism
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Swelling of uvula
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Arm 1 - Thalidomide Once Daily
n=23 participants at risk
Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
|
Arm 2 - Placebo Once Daily
n=16 participants at risk
Patients receive oral placebo once daily.
|
|---|---|---|
|
Nervous system disorders
Anxiety
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Anxiety/Depression
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Constipation
|
26.1%
6/23 • Number of events 6
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
Depression
|
8.7%
2/23 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 2
|
0.00%
0/16
|
|
Nervous system disorders
Euphoria
|
4.3%
1/23 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Fatigue
|
34.8%
8/23 • Number of events 8
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Libido
|
8.7%
2/23 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Libido/impotence
|
8.7%
2/23 • Number of events 2
|
0.00%
0/16
|
|
Nervous system disorders
Neuropathy
|
8.7%
2/23 • Number of events 2
|
0.00%
0/16
|
|
General disorders
Pelvic pain
|
4.3%
1/23 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral neuropathy
|
26.1%
6/23 • Number of events 7
|
31.2%
5/16 • Number of events 5
|
|
Nervous system disorders
Sedation
|
4.3%
1/23 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Skin changes
|
34.8%
8/23 • Number of events 8
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Weight gain
|
8.7%
2/23 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
Headaches
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
PTT
|
0.00%
0/23
|
6.2%
1/16 • Number of events 1
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place