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Trial record 7 of 104 for:    colon cancer | ( Map: Nebraska, United States )

Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00588900
Recruitment Status : Terminated
First Posted : January 9, 2008
Results First Posted : March 3, 2017
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: cediranib maleate
Drug: irinotecan hydrochloride
Enrollment 5
Recruitment Details Between March 2008 and May 2010, 5 participants were registered.
Pre-assignment Details  
Arm/Group Title Irinotecan + Cediranib
Hide Arm/Group Description Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Irinotecan + Cediranib
Hide Arm/Group Description Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
69.9
(52.3 to 80.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy
Hide Description The 12 week progression-free rate was defined as the percentage of patients that were alive and progression-free 12 weeks after start of second-line therapy. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions.
Time Frame at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Irinotecan + Cediranib
Hide Arm/Group Description:
Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
60
2.Secondary Outcome
Title Radiographic Response Rate
Hide Description

The proportion of patients who respond (completely or partially) to each combination regimen will be estimated.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.
Arm/Group Title Irinotecan + Cediranib
Hide Arm/Group Description:
Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.
Arm/Group Title Irinotecan + Cediranib
Hide Arm/Group Description:
Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 4 participants were evaluable for adverse events.
 
Arm/Group Title Irinotecan + Cediranib
Hide Arm/Group Description Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Irinotecan + Cediranib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Irinotecan + Cediranib
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  1/4 (25.00%)  1
Gastrointestinal disorders   
Colitis  1  1/4 (25.00%)  1
Diarrhea  1  2/4 (50.00%)  2
Enteritis  1  1/4 (25.00%)  1
Nausea  1  1/4 (25.00%)  1
Stomach pain  1  1/4 (25.00%)  1
Vomiting  1  1/4 (25.00%)  1
General disorders   
Fatigue  1  1/4 (25.00%)  1
Fever  1  1/4 (25.00%)  1
Investigations   
INR increased  1  1/4 (25.00%)  1
Neutrophil count decreased  1  1/4 (25.00%)  1
Platelet count decreased  1  1/4 (25.00%)  1
Weight loss  1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/4 (25.00%)  1
Nervous system disorders   
Seizure  1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Irinotecan + Cediranib
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Blood disorder  1  2/4 (50.00%)  4
Febrile neutropenia  1  1/4 (25.00%)  1
Hemoglobin decreased  1  1/4 (25.00%)  2
Cardiac disorders   
Atrial fibrillation  1  1/4 (25.00%)  2
Gastrointestinal disorders   
Abdominal pain  1  1/4 (25.00%)  4
Constipation  1  1/4 (25.00%)  1
Diarrhea  1  4/4 (100.00%)  18
Flatulence  1  1/4 (25.00%)  1
Gastritis  1  1/4 (25.00%)  2
Ileus  1  1/4 (25.00%)  1
Nausea  1  4/4 (100.00%)  7
Stomach pain  1  1/4 (25.00%)  1
Vomiting  1  2/4 (50.00%)  2
General disorders   
Fatigue  1  3/4 (75.00%)  10
Hepatobiliary disorders   
Hepatic pain  1  1/4 (25.00%)  1
Investigations   
Alanine aminotransferase increased  1  2/4 (50.00%)  4
Aspartate aminotransferase increased  1  1/4 (25.00%)  4
INR increased  1  1/4 (25.00%)  1
Laboratory test abnormal  1  1/4 (25.00%)  1
Leukocyte count decreased  1  1/4 (25.00%)  1
Neutrophil count decreased  1  3/4 (75.00%)  10
Platelet count decreased  1  2/4 (50.00%)  12
Metabolism and nutrition disorders   
Anorexia  1  1/4 (25.00%)  2
Blood glucose increased  1  1/4 (25.00%)  6
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/4 (25.00%)  1
Nervous system disorders   
Dizziness  1  1/4 (25.00%)  1
Peripheral sensory neuropathy  1  1/4 (25.00%)  4
Seizure  1  1/4 (25.00%)  1
Renal and urinary disorders   
Proteinuria  1  1/4 (25.00%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/4 (25.00%)  2
Dyspnea  1  1/4 (25.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  1/4 (25.00%)  5
Skin disorder  1  1/4 (25.00%)  1
Vascular disorders   
Hypertension  1  1/4 (25.00%)  4
Thrombosis  1  1/4 (25.00%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Bert O'Neil, M.D.
Organization: UNC Lineberger Comprehensive Cancer Center
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00588900     History of Changes
Other Study ID Numbers: CALGB-80502
CALGB-80502
CDR0000580967 ( Registry Identifier: NCI Physician Data Query )
First Submitted: December 20, 2007
First Posted: January 9, 2008
Results First Submitted: January 11, 2017
Results First Posted: March 3, 2017
Last Update Posted: April 5, 2017