Trial Outcomes & Findings for Doxorubicin and Bortezomib in Treating Patients With Liver Cancer (NCT NCT00083226)
NCT ID: NCT00083226
Last Updated: 2014-10-30
Results Overview
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.).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
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
Results posted on
2014-10-30
Participant Flow
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.
Participant milestones
| Measure |
Treatment (Doxorubicin+Bortezomib)
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 Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Treatment (Doxorubicin+Bortezomib)
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 Study
Lack of Efficacy
|
19
|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other
|
2
|
|
Overall Study
ineligible or not receiving treatment
|
4
|
Baseline Characteristics
Doxorubicin and Bortezomib in Treating Patients With Liver Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Doxorubicin+Bortezomib)
n=38 Participants
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
|
|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 yearPopulation: eligible and treated patients
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.).
Outcome measures
| Measure |
Treatment (Doxorubicin+Bortezomib)
n=38 Participants
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
|
|---|---|
|
Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)
|
3 percentage of participants
Interval 0.1 to 12.0
|
SECONDARY outcome
Timeframe: assessed every 3 months for 2 years and then every 6 months for 1 yearPopulation: eligible and treated
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.
Outcome measures
| Measure |
Treatment (Doxorubicin+Bortezomib)
n=38 Participants
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 Survival
|
6.4 months
Interval 4.4 to 8.5
|
SECONDARY outcome
Timeframe: 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.Population: eligible and treated patients with progression status information
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.
Outcome measures
| Measure |
Treatment (Doxorubicin+Bortezomib)
n=36 Participants
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
|
|---|---|
|
Progression Free Survival
|
2.2 months
Interval 2.0 to 3.4
|
Adverse Events
Doxorubicin+Bortezomib
Serious events: 28 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin+Bortezomib
n=39 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
28.2%
11/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
20.5%
8/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
41.0%
16/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
17.9%
7/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Activated partial thromboplastin time pr
|
7.7%
3/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
12.8%
5/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Doxorubicin+Bortezomib
n=39 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
84.6%
33/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
61.5%
24/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
41.0%
16/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
71.8%
28/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
56.4%
22/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
10.3%
4/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
INR increased
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Activated partial thromboplastin time pr
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
3/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.3%
4/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
35.9%
14/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
23.1%
9/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
28.2%
11/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
3/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
35.9%
14/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
17.9%
7/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
41.0%
16/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
61.5%
24/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
25.6%
10/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
23.1%
9/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
25.6%
10/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
12.8%
5/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
2/39 • Assessed every while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60