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Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer

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: NCT00093756
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : December 8, 2014
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Interventions Radiation: 3-dimensional conformal radiation therapy
Drug: bortezomib
Drug: paclitaxel
Drug: carboplatin
Enrollment 52
Recruitment Details  
Pre-assignment Details Fifty two (52) patients were accrued, out of which 4 were cancels. Twenty one (21) patients were accrued for phase I portion of the study. Twenty Seven (27) patients are accrued for phase II portion of the study. Twenty Seven (27) Phase II patients are evaluable for primary outcome measure.
Arm/Group Title Phase I Phase II
Hide Arm/Group Description PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV. PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
Period Title: Overall Study
Started 27 21
Completed 27 21
Not Completed 0 0
Arm/Group Title PhaseI PhaseII Total
Hide Arm/Group Description PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy> bortezomib: Given IV> paclitaxel: Given IV> carboplatin: Given IV PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy> bortezomib: Given IV> paclitaxel: Given IV> carboplatin: Given IV Total of all reporting groups
Overall Number of Baseline Participants 27 21 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 21 participants 48 participants
63
(45 to 78)
58
(43 to 79)
58
(43 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 21 participants 48 participants
Female
10
  37.0%
8
  38.1%
18
  37.5%
Male
17
  63.0%
13
  61.9%
30
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 21 participants 48 participants
21 27 48
1.Primary Outcome
Title The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only.
Hide Description The primary endpoint of this trial is the proportion of patients alive at 1 year (i.e., 365 days) after study registration. Proportion of successes, defined as the number of patients alive at one year divided by the total number of evaluable patients.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis included all 21 patients enrolled in the Phase II portion of the study and 6 patients enrolled in the Phase I who were treated at the Phase II dose level.
Arm/Group Title PhaseII
Hide Arm/Group Description:
PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: proportion of Participants
0.73
2.Secondary Outcome
Title Confirmed Tumor Response
Hide Description Response was assessed using the RECIST v1.1 criteria. Patients were evaluated at 4 weeks post-RT, 3 months post-RT, every 3 months for 1 year post-RT, and every 6 months thereafter for a maximum of 5 years from time of registration. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.
Arm/Group Title PhaseII
Hide Arm/Group Description:
PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
3
  11.1%
Partial Response (PR)
4
  14.8%
3.Secondary Outcome
Title Time to Progression
Hide Description The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time Frame From study registration to date of disease progression or date of last follow-up, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study team decision not to run this analysis.
Arm/Group Title Phase II
Hide Arm/Group Description:
PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression-free Survival
Hide Description The distribution of progression-free survival (PFS) is defined as the time from registration to the time of progression or death, whichever comes first. The PFS will be estimated using the method of Kaplan-Meier.
Time Frame From study registration to the first of either death due to any cause or progression, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.
Arm/Group Title Phase II
Hide Arm/Group Description:
PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
8.4
(4.1 to 10.5)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival is defined as the time from registration to the time to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame From registration to death due to any cause, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.
Arm/Group Title Phase II
Hide Arm/Group Description:
PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
25
(15.6 to 35.8)
6.Secondary Outcome
Title Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE)
Hide Description Toxicity was reported after the first 21 days of treatment and after each 28 day cycle thereafter. Events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. The number of patients reporting grade 3 and higher are tabulated.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.
Arm/Group Title Phase II
Hide Arm/Group Description:
PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3 Adverse Event
22
  81.5%
Grade 4 Adverse Event
15
  55.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PhaseI PhaseII
Hide Arm/Group Description PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV. PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
All-Cause Mortality
PhaseI PhaseII
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PhaseI PhaseII
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/21 (42.86%)      12/27 (44.44%)    
Cardiac disorders     
Arrhythmia supraventricular  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Left ventricular failure  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Myocardial ischemia  1  2/21 (9.52%)  2 0/27 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  1/21 (4.76%)  1 2/27 (7.41%)  2
Vomiting  1  1/21 (4.76%)  1 0/27 (0.00%)  0
General disorders     
Chest pain  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Fatigue  1  1/21 (4.76%)  1 2/27 (7.41%)  2
Infections and infestations     
Pneumonia  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Investigations     
Cardiac troponin I increased  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Leukocyte count decreased  1  1/21 (4.76%)  1 5/27 (18.52%)  5
Lymphocyte count decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  2
Neutrophil count decreased  1  1/21 (4.76%)  1 6/27 (22.22%)  6
Platelet count decreased  1  0/21 (0.00%)  0 9/27 (33.33%)  9
Metabolism and nutrition disorders     
Anorexia  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Dehydration  1  3/21 (14.29%)  3 0/27 (0.00%)  0
Serum albumin decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Serum calcium decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Serum phosphate decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Serum potassium decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Serum sodium decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  2
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Pain in extremity  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders     
Ataxia  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Depressed level of consciousness  1  0/21 (0.00%)  0 2/27 (7.41%)  2
Dizziness  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Dysgeusia  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Syncope  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  2/21 (9.52%)  2 2/27 (7.41%)  2
Hypoxia  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Pneumonitis  1  0/21 (0.00%)  0 2/27 (7.41%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Hypotension  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Thrombosis  1  2/21 (9.52%)  2 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PhaseI PhaseII
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/21 (100.00%)      27/27 (100.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  2/21 (9.52%)  2 1/27 (3.70%)  1
Hemoglobin decreased  1  17/21 (80.95%)  36 23/27 (85.19%)  64
Cardiac disorders     
Sinus tachycardia  1  0/21 (0.00%)  0 1/27 (3.70%)  2
Gastrointestinal disorders     
Constipation  1  4/21 (19.05%)  5 4/27 (14.81%)  5
Diarrhea  1  11/21 (52.38%)  15 9/27 (33.33%)  16
Dyspepsia  1  0/21 (0.00%)  0 2/27 (7.41%)  2
Dysphagia  1  17/21 (80.95%)  42 21/27 (77.78%)  40
Ear, nose and throat examination abnormal  1  6/21 (28.57%)  9 7/27 (25.93%)  8
Esophageal mucositis  1  6/21 (28.57%)  8 13/27 (48.15%)  17
Esophageal pain  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Esophagitis  1  0/21 (0.00%)  0 1/27 (3.70%)  2
Mucositis oral  1  5/21 (23.81%)  8 9/27 (33.33%)  13
Nausea  1  15/21 (71.43%)  24 21/27 (77.78%)  35
Vomiting  1  7/21 (33.33%)  10 12/27 (44.44%)  18
General disorders     
Chest pain  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Fatigue  1  20/21 (95.24%)  60 26/27 (96.30%)  68
Fever  1  4/21 (19.05%)  4 4/27 (14.81%)  5
Pain  1  1/21 (4.76%)  2 0/27 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/21 (0.00%)  0 2/27 (7.41%)  2
Infections and infestations     
Gingival infection  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Paranasal sinus infection  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Upper respiratory infection  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Injury, poisoning and procedural complications     
Radiation recall reaction (dermatologic)  1  10/21 (47.62%)  14 14/27 (51.85%)  21
Investigations     
Alkaline phosphatase increased  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Creatinine increased  1  0/21 (0.00%)  0 1/27 (3.70%)  1
INR increased  1  1/21 (4.76%)  2 0/27 (0.00%)  0
Leukocyte count decreased  1  19/21 (90.48%)  36 22/27 (81.48%)  43
Lymphocyte count decreased  1  3/21 (14.29%)  4 1/27 (3.70%)  1
Neutrophil count decreased  1  17/21 (80.95%)  24 20/27 (74.07%)  34
Platelet count decreased  1  13/21 (61.90%)  19 23/27 (85.19%)  31
Weight loss  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Metabolism and nutrition disorders     
Anorexia  1  5/21 (23.81%)  5 4/27 (14.81%)  4
Blood glucose increased  1  2/21 (9.52%)  2 0/27 (0.00%)  0
Dehydration  1  4/21 (19.05%)  4 3/27 (11.11%)  3
Serum albumin decreased  1  1/21 (4.76%)  2 1/27 (3.70%)  2
Serum calcium decreased  1  1/21 (4.76%)  1 1/27 (3.70%)  2
Serum magnesium decreased  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Serum sodium decreased  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Bone pain  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Chest wall pain  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Muscle weakness  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Myalgia  1  7/21 (33.33%)  10 12/27 (44.44%)  27
Pain in extremity  1  1/21 (4.76%)  1 1/27 (3.70%)  2
Nervous system disorders     
Ataxia  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Depressed level of consciousness  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Dizziness  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Dysgeusia  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Extrapyramidal disorder  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Headache  1  1/21 (4.76%)  1 1/27 (3.70%)  2
Neuralgia  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Peripheral motor neuropathy  1  1/21 (4.76%)  1 1/27 (3.70%)  3
Peripheral sensory neuropathy  1  11/21 (52.38%)  27 15/27 (55.56%)  38
Syncope  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Psychiatric disorders     
Anxiety  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Confusion  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Insomnia  1  0/21 (0.00%)  0 2/27 (7.41%)  2
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Cough  1  2/21 (9.52%)  3 1/27 (3.70%)  1
Dyspnea  1  14/21 (66.67%)  51 21/27 (77.78%)  45
Hiccups  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Laryngeal stenosis  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Pharyngeal examination abnormal  1  4/21 (19.05%)  5 4/27 (14.81%)  4
Pneumonitis  1  5/21 (23.81%)  6 2/27 (7.41%)  3
Pneumothorax  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Respiratory disorder  1  1/21 (4.76%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  4/21 (19.05%)  5 9/27 (33.33%)  13
Rash desquamating  1  1/21 (4.76%)  1 1/27 (3.70%)  1
Skin disorder  1  0/21 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Hypotension  1  3/21 (14.29%)  4 1/27 (3.70%)  1
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
Layout table for Results Point of Contact information
Name/Title: Alex A. Adjei, M.D., Ph.D.
Organization: Roswell Park Cancer Institute
Phone: 507/284- 9265
EMail: alex.adjei@roswellpark.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093756    
Other Study ID Numbers: NCI-2009-00643
NCI-2009-00643 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000390108
NCCTG-N0321
N0321 ( Other Identifier: North Central Cancer Treatment Group )
N0321 ( Other Identifier: CTEP )
U10CA025224 ( U.S. NIH Grant/Contract )
First Submitted: October 6, 2004
First Posted: October 8, 2004
Results First Submitted: November 25, 2013
Results First Posted: December 8, 2014
Last Update Posted: December 7, 2017