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S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00368992
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : September 14, 2015
Last Update Posted : September 14, 2015
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 Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions Biological: cetuximab
Drug: paclitaxel
Biological: bevacizumab
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description

This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 110
Completed 0
Not Completed 110
Reason Not Completed
Ineligible             5
Refused treatment             3
Lack of Efficacy             63
Adverse Event             26
Death             4
Not Specified             9
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description This was a single arm Phase II trial. Patients were treated until progression.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 102 participants
64
(42 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
50
  49.0%
Male
52
  51.0%
1.Primary Outcome
Title The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.
Hide Description All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.
Time Frame Every week until removed from protocol therapy, up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment were included in the analysis.
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2
(0 to 7)
2.Secondary Outcome
Title Progression-Free Survival
Hide Description From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
Time Frame Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment were included in the analysis.
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description:
This was a single arm Phase II trial. Patients were treated until progression.
Overall Number of Participants Analyzed 102
Median (95% Confidence Interval)
Unit of Measure: Months
7
(6 to 8)
3.Secondary Outcome
Title Overall Survival
Hide Description From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.
Time Frame Once a week, up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment were included in the analysis.
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description:
This was a single arm Phase II trial. Patients were treated until progression.
Overall Number of Participants Analyzed 102
Median (95% Confidence Interval)
Unit of Measure: months
15
(11 to 21)
4.Secondary Outcome
Title Response Rate
Hide Description Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a >= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.
Time Frame Every 6 weeks while on protocol treatment, up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(44 to 65)
Time Frame Weekly while on protocol treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Affected / at Risk (%)
Total   51/102 (50.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  5/102 (4.90%) 
Hemoglobin  1  1/102 (0.98%) 
Cardiac disorders   
Cardiac-ischemia/infarction  1  1/102 (0.98%) 
Left ventricular diastolic dysfunction  1  1/102 (0.98%) 
Left ventricular systolic dysfunction  1  1/102 (0.98%) 
Ventricular arrhythmia - Ventricular tachycardia  1  1/102 (0.98%) 
Eye disorders   
Ocular/Visual-Other (Specify)  1  1/102 (0.98%) 
Gastrointestinal disorders   
Constipation  1  2/102 (1.96%) 
Diarrhea  1  2/102 (1.96%) 
Gastritis (including bile reflux gastritis)  1  1/102 (0.98%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  2/102 (1.96%) 
Nausea  1  5/102 (4.90%) 
Obstruction, GI - Small bowel NOS  1  1/102 (0.98%) 
Pain - Abdomen NOS  1  1/102 (0.98%) 
Vomiting  1  2/102 (1.96%) 
General disorders   
Death not associated with CTCAE term - Death NOS  1  2/102 (1.96%) 
Fatigue (asthenia, lethargy, malaise)  1  6/102 (5.88%) 
Sudden death  1  1/102 (0.98%) 
Immune system disorders   
Cytokine release syndrome/acute infusion reaction  1  1/102 (0.98%) 
Infections and infestations   
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  1/102 (0.98%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Colon  1  1/102 (0.98%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  4/102 (3.92%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus  1  1/102 (0.98%) 
Inf (clin/microbio) w/Gr 3-4 neuts - UTI  1  1/102 (0.98%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/102 (0.98%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Joint  1  1/102 (0.98%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  3/102 (2.94%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear  1  1/102 (0.98%) 
Infection with unknown ANC - Blood  1  1/102 (0.98%) 
Investigations   
Leukocytes (total WBC)  1  3/102 (2.94%) 
Lymphopenia  1  1/102 (0.98%) 
Neutrophils/granulocytes (ANC/AGC)  1  16/102 (15.69%) 
Platelets  1  2/102 (1.96%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  1/102 (0.98%) 
Anorexia  1  3/102 (2.94%) 
Dehydration  1  7/102 (6.86%) 
Magnesium, serum-low (hypomagnesemia)  1  2/102 (1.96%) 
Potassium, serum-low (hypokalemia)  1  2/102 (1.96%) 
Sodium, serum-low (hyponatremia)  1  1/102 (0.98%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - body/general  1  3/102 (2.94%) 
Musculoskeletal/Soft Tissue-Other (Specify)  1  1/102 (0.98%) 
Pain - Back  1  2/102 (1.96%) 
Pain - Buttock  1  1/102 (0.98%) 
Pain - Chest wall  1  1/102 (0.98%) 
Pain - Joint  1  2/102 (1.96%) 
Pain - Muscle  1  1/102 (0.98%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  3/102 (2.94%) 
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/102 (0.98%) 
Neuropathy: motor  1  1/102 (0.98%) 
Neuropathy: sensory  1  1/102 (0.98%) 
Ocular/Visual-Other (Specify)  1  1/102 (0.98%) 
Seizure  1  1/102 (0.98%) 
Syncope (fainting)  1  2/102 (1.96%) 
Reproductive system and breast disorders   
Vaginitis (not due to infection)  1  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  9/102 (8.82%) 
Hemorrhage, pulmonary/upper respiratory - Lung  1  2/102 (1.96%) 
Hypoxia  1  3/102 (2.94%) 
Pain - Pleura  1  1/102 (0.98%) 
Pleural effusion (non-malignant)  1  1/102 (0.98%) 
Pneumonitis/pulmonary infiltrates  1  4/102 (3.92%) 
Pneumothorax  1  2/102 (1.96%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  2/102 (1.96%) 
Vascular disorders   
Hypertension  1  1/102 (0.98%) 
Hypotension  1  2/102 (1.96%) 
Phlebitis (including superficial thrombosis)  1  1/102 (0.98%) 
Thrombosis/thrombus/embolism  1  7/102 (6.86%) 
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%
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Affected / at Risk (%)
Total   101/102 (99.02%) 
Blood and lymphatic system disorders   
Hemoglobin  1  58/102 (56.86%) 
Eye disorders   
Vision-blurred vision  1  6/102 (5.88%) 
Gastrointestinal disorders   
Constipation  1  57/102 (55.88%) 
Diarrhea  1  45/102 (44.12%) 
Dysphagia (difficulty swallowing)  1  7/102 (6.86%) 
Heartburn/dyspepsia  1  15/102 (14.71%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  36/102 (35.29%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  21/102 (20.59%) 
Nausea  1  53/102 (51.96%) 
Pain - Abdomen NOS  1  11/102 (10.78%) 
Pain - Oral cavity  1  6/102 (5.88%) 
Vomiting  1  25/102 (24.51%) 
General disorders   
Edema: limb  1  10/102 (9.80%) 
Fatigue (asthenia, lethargy, malaise)  1  88/102 (86.27%) 
Pain - Chest/thorax NOS  1  10/102 (9.80%) 
Pain-Other (Specify)  1  14/102 (13.73%) 
Rigors/chills  1  6/102 (5.88%) 
Immune system disorders   
Allergic reaction/hypersensitivity  1  14/102 (13.73%) 
Infections and infestations   
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  11/102 (10.78%) 
Infection-Other (Specify)  1  8/102 (7.84%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  22/102 (21.57%) 
AST, SGOT  1  22/102 (21.57%) 
Alkaline phosphatase  1  31/102 (30.39%) 
Bilirubin (hyperbilirubinemia)  1  8/102 (7.84%) 
Creatinine  1  6/102 (5.88%) 
Leukocytes (total WBC)  1  52/102 (50.98%) 
Lymphopenia  1  9/102 (8.82%) 
Metabolic/Laboratory-Other (Specify)  1  6/102 (5.88%) 
Neutrophils/granulocytes (ANC/AGC)  1  62/102 (60.78%) 
Platelets  1  40/102 (39.22%) 
Weight loss  1  40/102 (39.22%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  30/102 (29.41%) 
Anorexia  1  43/102 (42.16%) 
Calcium, serum-low (hypocalcemia)  1  31/102 (30.39%) 
Dehydration  1  17/102 (16.67%) 
Glucose, serum-high (hyperglycemia)  1  56/102 (54.90%) 
Glucose, serum-low (hypoglycemia)  1  11/102 (10.78%) 
Magnesium, serum-low (hypomagnesemia)  1  50/102 (49.02%) 
Potassium, serum-high (hyperkalemia)  1  11/102 (10.78%) 
Potassium, serum-low (hypokalemia)  1  21/102 (20.59%) 
Sodium, serum-low (hyponatremia)  1  29/102 (28.43%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - Extrem-lower  1  8/102 (7.84%) 
Muscle weakness, not d/t neuropathy - body/general  1  14/102 (13.73%) 
Pain - Back  1  19/102 (18.63%) 
Pain - Bone  1  17/102 (16.67%) 
Pain - Chest wall  1  9/102 (8.82%) 
Pain - Extremity-limb  1  20/102 (19.61%) 
Pain - Joint  1  32/102 (31.37%) 
Pain - Muscle  1  24/102 (23.53%) 
Nervous system disorders   
Dizziness  1  21/102 (20.59%) 
Neuropathy: motor  1  11/102 (10.78%) 
Neuropathy: sensory  1  76/102 (74.51%) 
Pain - Head/headache  1  13/102 (12.75%) 
Taste alteration (dysgeusia)  1  25/102 (24.51%) 
Psychiatric disorders   
Insomnia  1  19/102 (18.63%) 
Mood alteration - anxiety  1  15/102 (14.71%) 
Mood alteration - depression  1  19/102 (18.63%) 
Renal and urinary disorders   
Proteinuria  1  13/102 (12.75%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  10/102 (9.80%) 
Cough  1  27/102 (26.47%) 
Dyspnea (shortness of breath)  1  44/102 (43.14%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  27/102 (26.47%) 
Mucositis/stomatitis (functional/symp) - Pharynx  1  7/102 (6.86%) 
Nasal cavity/paranasal sinus reactions  1  8/102 (7.84%) 
Voice changes/dysarthria  1  21/102 (20.59%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify)  1  16/102 (15.69%) 
Dry skin  1  26/102 (25.49%) 
Hair loss/Alopecia (scalp or body)  1  50/102 (49.02%) 
Nail changes  1  6/102 (5.88%) 
Pruritus/itching  1  22/102 (21.57%) 
Rash/desquamation  1  31/102 (30.39%) 
Rash: acne/acneiform  1  78/102 (76.47%) 
Rash: hand-foot skin reaction  1  9/102 (8.82%) 
Vascular disorders   
Hypertension  1  25/102 (24.51%) 
Hypotension  1  12/102 (11.76%) 
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
Name/Title: Lung Committee Statistician
Organization: SWOG
Phone: 206-667-4623
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00368992     History of Changes
Other Study ID Numbers: NCI-2012-02903
S0536
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: October 30, 2012
Results First Posted: September 14, 2015
Last Update Posted: September 14, 2015