Trial Outcomes & Findings for Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck (NCT NCT00581360)
NCT ID: NCT00581360
Last Updated: 2016-11-07
Results Overview
ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): 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; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s
COMPLETED
PHASE2
10 participants
Up to 5 years
2016-11-07
Participant Flow
Participant milestones
| Measure |
Bortezomib + Doxorubicin
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Bortezomib + Doxorubicin
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Bortezomib + Doxorubicin
n=9 Participants
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): 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; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s
Outcome measures
| Measure |
Bortezomib + Doxorubicin
n=9 Participants
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All patients in this population had stable disease as best response.
Using RECIST v1.0 criteria, stable disease rate is the number participants experiencing stable disease (SD) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD).
Outcome measures
| Measure |
Bortezomib + Doxorubicin
n=9 Participants
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Stable Disease Rate
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of months that participants experienced stable disease (the disease does not progress per RECIST v1.0 criteria - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)
Outcome measures
| Measure |
Bortezomib + Doxorubicin
n=9 Participants
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Number of Months of Progression-free Survival (PFS)
Participant 1
|
8 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 2
|
23 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 3
|
36 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 4
|
4 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 5
|
2 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 6
|
8 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 7
|
26 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 8
|
5 months
|
|
Number of Months of Progression-free Survival (PFS)
Participant 9
|
1 months
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of months that the participant was alive.
Outcome measures
| Measure |
Bortezomib + Doxorubicin
n=9 Participants
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Number of Months of Survival
Participant 1
|
29.13 months
|
|
Number of Months of Survival
Participant 2
|
23.40 months
|
|
Number of Months of Survival
Participant 3
|
34.50 months
|
|
Number of Months of Survival
Participant 4
|
8.03 months
|
|
Number of Months of Survival
Participant 5
|
12.20 months
|
|
Number of Months of Survival
Participant 6
|
16.10 months
|
|
Number of Months of Survival
Participant 7
|
25.93 months
|
|
Number of Months of Survival
Participant 8
|
24.97 months
|
|
Number of Months of Survival
Participant 9
|
1.27 months
|
SECONDARY outcome
Timeframe: Up to 36 monthsMedian number of months of Stable Disease Response Per RECIST v1.0 (Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)
Outcome measures
| Measure |
Bortezomib + Doxorubicin
n=9 Participants
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Median Duration of Stable Disease Response
|
8 months
Interval 1.0 to 36.0
|
Adverse Events
Bortezomib + Doxorubicin
Serious adverse events
| Measure |
Bortezomib + Doxorubicin
n=9 participants at risk
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Cardiac disorders
Hypotension
|
11.1%
1/9
|
|
General disorders
Constipation
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Local complication -device/prosthesis-related
|
11.1%
1/9
|
|
General disorders
Pain, Abdomen NOS
|
11.1%
1/9
|
|
General disorders
Pain, Chest/thorax NOS
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
22.2%
2/9
|
Other adverse events
| Measure |
Bortezomib + Doxorubicin
n=9 participants at risk
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Hemoglobin
|
55.6%
5/9
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
66.7%
6/9
|
|
Blood and lymphatic system disorders
Platelets
|
33.3%
3/9
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
55.6%
5/9
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
22.2%
2/9
|
|
General disorders
Sweating (diaphoresis)
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
11.1%
1/9
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9
|
|
Gastrointestinal disorders
Constipation
|
55.6%
5/9
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
11.1%
1/9
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
11.1%
1/9
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
11.1%
1/9
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
11.1%
1/9
|
|
Gastrointestinal disorders
Nausea
|
77.8%
7/9
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory, Nose
|
11.1%
1/9
|
|
Infections and infestations
Infection - Other (Specify, __)
|
22.2%
2/9
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Edema: limb
|
11.1%
1/9
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
11.1%
1/9
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
22.2%
2/9
|
|
Investigations
Magnesium, serum-low (hypomagnesemia)
|
11.1%
1/9
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
11.1%
1/9
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9
|
|
Nervous system disorders
Neuropathy: motor
|
11.1%
1/9
|
|
Nervous system disorders
Neuropathy: sensory
|
22.2%
2/9
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
11.1%
1/9
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
11.1%
1/9
|
|
General disorders
Pain - Other (Specify, __)
|
11.1%
1/9
|
|
General disorders
Pain, Abdomen NOS
|
11.1%
1/9
|
|
General disorders
Pain, Chest wall
|
11.1%
1/9
|
|
General disorders
Pain, Extremity-limb
|
22.2%
2/9
|
|
General disorders
Pain, Head/headache
|
33.3%
3/9
|
|
General disorders
Pain, Joint
|
11.1%
1/9
|
|
General disorders
Pain, Pain NOS
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway, Bronchus
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
11.1%
1/9
|
|
Renal and urinary disorders
Urine color change
|
11.1%
1/9
|
Additional Information
Rita Johnson, Associate Director of Clinical Research Services
Clinical Research Services, UPCI
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place