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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

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ClinicalTrials.gov Identifier: NCT00310076
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : August 28, 2012
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma of the Appendix
Colorectal Cancer
Interventions Drug: thalidomide
Procedure: surgery
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemo Therapy Followed by Thalidomide
Hide Arm/Group Description After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Period Title: Overall Study
Started 29
Completed 26
Not Completed 3
Arm/Group Title Chemo Therapy Followed by Thalidomide
Hide Arm/Group Description After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  96.2%
>=65 years
1
   3.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
51  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
13
  50.0%
Male
13
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Time to Progression
Hide Description Time to progression after surgery was recorded.
Time Frame 9 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemo Therapy Followed by Thalidomide
Hide Arm/Group Description:
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: years
0.775
(0.42 to 3.38)
2.Secondary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame 60 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemo Therapy Followed by Thalidomide
Hide Arm/Group Description:
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: years
0.775
(0.42 to 3.38)
3.Secondary Outcome
Title Number of Events of Toxicity Graded 3 and 4
Hide Description Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported
Time Frame up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemo Therapy Followed by Thalidomide
Hide Arm/Group Description:
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: number of events
Grade 3 17
Grade 4 4
Time Frame up to 60 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemo Therapy Followed by Thalidomide
Hide Arm/Group Description After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
All-Cause Mortality
Chemo Therapy Followed by Thalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemo Therapy Followed by Thalidomide
Affected / at Risk (%) # Events
Total   15/27 (55.56%)    
Blood and lymphatic system disorders   
Hemorrhage  1  1/27 (3.70%)  1
Cardiac disorders   
Cardiac Dysrhythmias  1  1/27 (3.70%)  1
Cardiovascular/General-other  1  1/27 (3.70%)  1
Thrombosis/Embolism  1  2/27 (7.41%)  2
Gastrointestinal disorders   
Constipation  1  2/27 (7.41%)  2
Diarrhea  1  1/27 (3.70%)  1
other gastrointestinal  1  1/27 (3.70%)  1
Nausea  1  3/27 (11.11%)  3
Vomiting  1  3/27 (11.11%)  3
General disorders   
Dysphagia, esophagitis, odynophagia  1  1/27 (3.70%)  1
Fatigue  1  1/27 (3.70%)  1
Hypertension  1  1/27 (3.70%)  1
Hypotension  1  1/27 (3.70%)  1
Hypoxia  1  1/27 (3.70%)  1
Weight Gain  1  2/27 (7.41%)  2
Infections and infestations   
Infection with unknown ANC  1  3/27 (11.11%)  3
Infection/Febrile Neutropenia-Other  1  1/27 (3.70%)  1
Investigations   
Creatinine  1  1/27 (3.70%)  1
Hemoglobin  1  1/27 (3.70%)  1
Hypokalemia  1  2/27 (7.41%)  2
Hypomagnesemia  1  1/27 (3.70%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/27 (3.70%)  1
Nervous system disorders   
Neurosensory  1  5/27 (18.52%)  5
Pain-other  1  2/27 (7.41%)  2
Psychiatric disorders   
Neuro-mood  1  2/27 (7.41%)  2
Neuro-motor  1  2/27 (7.41%)  2
Renal and urinary disorders   
Ureteral Obstruction  1  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/27 (3.70%)  1
Dyspnea  1  1/27 (3.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemo Therapy Followed by Thalidomide
Affected / at Risk (%) # Events
Total   27/27 (100.00%)    
Ear and labyrinth disorders   
Auditory/Ear-Other  1  2/27 (7.41%)  2
Endocrine disorders   
Endocrine Other  1  3/27 (11.11%)  3
General disorders   
Anorexia  1  3/27 (11.11%)  3
Alopecia  1  5/27 (18.52%)  5
Dizziness/vertigo  1  4/27 (14.81%)  4
Insomnia  1  2/27 (7.41%)  2
Weight Loss  1  4/27 (14.81%)  4
Hot flashes/flushes  1  2/27 (7.41%)  2
Somnolence  1  5/27 (18.52%)  5
Infections and infestations   
Infection-Other  1  2/27 (7.41%)  2
Investigations   
Leukocytes  1  10/27 (37.04%)  10
Alk Phos  1  8/27 (29.63%)  8
Absolute Neutrophil Count  1  3/27 (11.11%)  3
Hyperglycemia  1  14/27 (51.85%)  14
Hypoglycemia  1  2/27 (7.41%)  2
Hypocalcemia  1  8/27 (29.63%)  8
Hyponatremia  1  2/27 (7.41%)  2
Coagulation Other  1  2/27 (7.41%)  2
Hypoalbuminemia  1  4/27 (14.81%)  4
Serum glutamic pyruvic transaminase  1  7/27 (25.93%)  7
Serum glutamic oxaloacetic transaminase  1  5/27 (18.52%)  5
Hyperkalemia  1  4/27 (14.81%)  4
Hypernatremia  1  3/27 (11.11%)  3
Fever in the absence of neutropenia  1  2/27 (7.41%)  2
Metabolism and nutrition disorders   
Edema  1  3/27 (11.11%)  3
Nervous system disorders   
Neurologic Other  1  9/27 (33.33%)  9
Skin and subcutaneous tissue disorders   
Dermatological  1  7/27 (25.93%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Greg Russell, MS
Organization: Comprehensive Cancer Center of Wake Forest University
Phone: 336-716-5449
EMail: grussell@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00310076     History of Changes
Other Study ID Numbers: CDR0000466311
CCCWFU-59202
CCCWFU-BG02-406
CELGENE-CCCWFU-59202
First Submitted: March 29, 2006
First Posted: April 3, 2006
Results First Submitted: July 24, 2012
Results First Posted: August 28, 2012
Last Update Posted: August 23, 2018