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Trial record 91 of 2029 for:    doxil

Doxorubicin and Bortezomib in Treating Patients With Liver Cancer

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ClinicalTrials.gov Identifier: NCT00083226
Recruitment Status : Completed
First Posted : May 17, 2004
Results First Posted : October 30, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Interventions Drug: doxorubicin
Drug: bortezomib
Enrollment 42
Recruitment Details This study was activated on March 19, 2004 and terminated on February 12,2007 after meeting its accrual goal of 40 patients. The final accrual of the study was 42 patients, enrolled through 4 ECOG member institutions.
Pre-assignment Details  
Arm/Group Title Treatment (Doxorubicin+Bortezomib)
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Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV

Period Title: Overall Study
Started 42
Completed 0
Not Completed 42
Reason Not Completed
Lack of Efficacy             19
Adverse Event             9
Death             4
Withdrawal by Subject             4
Other             2
ineligible or not receiving treatment             4
Arm/Group Title Treatment (Doxorubicin+Bortezomib)
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Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
The primary population was the 38 eligible and treated patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
57.1  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
11
  28.9%
Male
27
  71.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)
Hide Description Tumor response was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Objective response rate included complete response (disappearance of all tumor lesions) and partial response (At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.).
Time Frame assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year
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Hide Analysis Population Description
eligible and treated patients
Arm/Group Title Treatment (Doxorubicin+Bortezomib)
Hide Arm/Group Description:

Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV

Overall Number of Participants Analyzed 38
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
3
(0.1 to 12)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as time from registration to death from any cause. Patients alive were censored at follow up. Analysis was conducted in the 38 eligible and treated patients.
Time Frame assessed every 3 months for 2 years and then every 6 months for 1 year
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Hide Analysis Population Description
eligible and treated
Arm/Group Title Treatment (Doxorubicin+Bortezomib)
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Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV

Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: months
6.4
(4.4 to 8.5)
3.Secondary Outcome
Title Progression Free Survival
Hide Description Time from registration to disease progression or death, whichever occurred earlier. Patients alive and progression-free were censored at last follow up. 36 eligible and treated patients were included in the analysis. The other 2 eligible and treated patients had no disease status information.
Time Frame assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
eligible and treated patients with progression status information
Arm/Group Title Treatment (Doxorubicin+Bortezomib)
Hide Arm/Group Description:

Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.

doxorubicin: Given IV

bortezomib: Given IV

Overall Number of Participants Analyzed 36
Median (95% Confidence Interval)
Unit of Measure: months
2.2
(2.0 to 3.4)
Time Frame Assessed every while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxorubicin+Bortezomib
Hide Arm/Group Description Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
All-Cause Mortality
Doxorubicin+Bortezomib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxorubicin+Bortezomib
Affected / at Risk (%)
Total   28/39 (71.79%) 
Blood and lymphatic system disorders   
Anemia  1  2/39 (5.13%) 
Gastrointestinal disorders   
Diarrhea w/o prior colostomy  1  5/39 (12.82%) 
Dysphagia  1  1/39 (2.56%) 
Ileus  1  1/39 (2.56%) 
Nausea  1  1/39 (2.56%) 
Vomiting  1  1/39 (2.56%) 
Abdomen, pain  1  1/39 (2.56%) 
General disorders   
Fatigue  1  7/39 (17.95%) 
Infections and infestations   
Infection w/ gr3-4 neut, lung  1  1/39 (2.56%) 
Investigations   
Leukocytes decreased  1  11/39 (28.21%) 
Neutrophils decreased  1  8/39 (20.51%) 
Platelets decreased  1  16/39 (41.03%) 
Activated partial thromboplastin time pr  1  3/39 (7.69%) 
Alkaline phosphatase increased  1  1/39 (2.56%) 
Aspartate aminotransferase increased  1  2/39 (5.13%) 
Metabolism and nutrition disorders   
Dehydration  1  2/39 (5.13%) 
Hyperglycemia  1  1/39 (2.56%) 
Hyponatremia  1  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/39 (2.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxorubicin+Bortezomib
Affected / at Risk (%)
Total   36/39 (92.31%) 
Blood and lymphatic system disorders   
Anemia  1  33/39 (84.62%) 
Gastrointestinal disorders   
Constipation  1  9/39 (23.08%) 
Diarrhea w/o prior colostomy  1  11/39 (28.21%) 
Dyspepsia  1  3/39 (7.69%) 
Muco/stomatitis (symptom) oral cavity  1  2/39 (5.13%) 
Nausea  1  14/39 (35.90%) 
Vomiting  1  5/39 (12.82%) 
Abdomen, pain  1  5/39 (12.82%) 
General disorders   
Fatigue  1  22/39 (56.41%) 
Fever w/o neutropenia  1  2/39 (5.13%) 
Edema limb  1  2/39 (5.13%) 
Investigations   
Leukocytes decreased  1  24/39 (61.54%) 
Neutrophils decreased  1  16/39 (41.03%) 
Platelets decreased  1  28/39 (71.79%) 
Weight loss  1  4/39 (10.26%) 
INR increased  1  2/39 (5.13%) 
Activated partial thromboplastin time pr  1  2/39 (5.13%) 
Alkaline phosphatase increased  1  16/39 (41.03%) 
Aspartate aminotransferase increased  1  24/39 (61.54%) 
Blood bilirubin increased  1  10/39 (25.64%) 
Creatinine increased  1  9/39 (23.08%) 
Metabolism and nutrition disorders   
Anorexia  1  14/39 (35.90%) 
Hyponatremia  1  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders   
Muscle, pain  1  2/39 (5.13%) 
Nervous system disorders   
Taste disturbance  1  7/39 (17.95%) 
Neuropathy-sensory  1  10/39 (25.64%) 
Psychiatric disorders   
Insomnia  1  2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders   
Nose, hemorrhage  1  2/39 (5.13%) 
Dyspnea  1  2/39 (5.13%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  3/39 (7.69%) 
Pruritus/itching  1  4/39 (10.26%) 
Skin-other  1  2/39 (5.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
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
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083226     History of Changes
Other Study ID Numbers: NCI-2014-00654
NCI-2012-02952 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E6202 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2004
First Posted: May 17, 2004
Results First Submitted: October 24, 2014
Results First Posted: October 30, 2014
Last Update Posted: October 30, 2014