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Trial record 47 of 2158 for:    doxorubicin

Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck

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ClinicalTrials.gov Identifier: NCT00581360
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenoid Cystic Carcinoma
Intervention Drug: doxorubicin and bortezomib
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
56
(44 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description:
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Primary Outcome
Title Stable Disease Rate
Hide Description 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).
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in this population had stable disease as best response.
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description:
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Number of Months of Progression-free Survival (PFS)
Hide Description Number 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)
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description:
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: months
Participant 1 8
Participant 2 23
Participant 3 36
Participant 4 4
Participant 5 2
Participant 6 8
Participant 7 26
Participant 8 5
Participant 9 1
4.Secondary Outcome
Title Number of Months of Survival
Hide Description Number of months that the participant was alive.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description:
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: months
Participant 1 29.13
Participant 2 23.40
Participant 3 34.50
Participant 4 8.03
Participant 5 12.20
Participant 6 16.10
Participant 7 25.93
Participant 8 24.97
Participant 9 1.27
5.Secondary Outcome
Title Median Duration of Stable Disease Response
Hide Description Median 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)
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description:
Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: months
8
(1 to 36)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortezomib + Doxorubicin
Hide Arm/Group Description Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
All-Cause Mortality
Bortezomib + Doxorubicin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib + Doxorubicin
Affected / at Risk (%)
Total   3/9 (33.33%) 
Cardiac disorders   
Hypotension  1/9 (11.11%) 
General disorders   
Constipation  1/9 (11.11%) 
Pain, Abdomen NOS  1/9 (11.11%) 
Pain, Chest/thorax NOS  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Local complication -device/prosthesis-related  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  2/9 (22.22%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bortezomib + Doxorubicin
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  5/9 (55.56%) 
Leukocytes (total WBC)  1/9 (11.11%) 
Neutrophils/granulocytes (ANC/AGC)  6/9 (66.67%) 
Platelets  3/9 (33.33%) 
Edema: limb  1/9 (11.11%) 
Eye disorders   
Ocular/Visual - Other (Specify, __)  1/9 (11.11%) 
Watery eye (epiphora, tearing)  1/9 (11.11%) 
Gastrointestinal disorders   
Anorexia  1/9 (11.11%) 
Constipation  5/9 (55.56%) 
Diarrhea  2/9 (22.22%) 
Dry mouth/salivary gland (xerostomia)  1/9 (11.11%) 
Dysphagia (difficulty swallowing)  1/9 (11.11%) 
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)  1/9 (11.11%) 
Mucositis/stomatitis (clinical exam), Oral cavity  1/9 (11.11%) 
Nausea  7/9 (77.78%) 
Vomiting  3/9 (33.33%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  5/9 (55.56%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  2/9 (22.22%) 
Sweating (diaphoresis)  1/9 (11.11%) 
Pain - Other (Specify, __)  1/9 (11.11%) 
Pain, Abdomen NOS  1/9 (11.11%) 
Pain, Chest wall  1/9 (11.11%) 
Pain, Extremity-limb  2/9 (22.22%) 
Pain, Head/headache  3/9 (33.33%) 
Pain, Joint  1/9 (11.11%) 
Pain, Pain NOS  2/9 (22.22%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1/9 (11.11%) 
Infections and infestations   
Infection - Other (Specify, __)  2/9 (22.22%) 
Opportunistic infection associated with >=Grade 2 Lymphopenia  1/9 (11.11%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1/9 (11.11%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  2/9 (22.22%) 
Magnesium, serum-low (hypomagnesemia)  1/9 (11.11%) 
Potassium, serum-low (hypokalemia)  1/9 (11.11%) 
Sodium, serum-low (hyponatremia)  1/9 (11.11%) 
Nervous system disorders   
Dizziness  2/9 (22.22%) 
Neuropathy: motor  1/9 (11.11%) 
Neuropathy: sensory  2/9 (22.22%) 
Renal and urinary disorders   
Urine color change  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Obstruction/stenosis of airway, Bronchus  1/9 (11.11%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify, __)  1/9 (11.11%) 
Dry skin  1/9 (11.11%) 
Hair loss/alopecia (scalp or body)  1/9 (11.11%) 
Rash/desquamation  2/9 (22.22%) 
Rash: acne/acneiform  2/9 (22.22%) 
Urticaria (hives, welts, wheals)  1/9 (11.11%) 
Vascular disorders   
Hemorrhage, pulmonary/upper respiratory, Nose  1/9 (11.11%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Rita Johnson, Associate Director of Clinical Research Services
Organization: Clinical Research Services, UPCI
Phone: 412-647-8571
EMail: johnsonr1@upmc.edu
Layout table for additonal information
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00581360     History of Changes
Other Study ID Numbers: 06-124
First Submitted: December 19, 2007
First Posted: December 27, 2007
Results First Submitted: January 14, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016