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Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers

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: NCT01344824
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : July 11, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Biological: bevacizumab
Drug: carboplatin
Drug: erlotinib hydrochloride
Drug: pemetrexed disodium
Enrollment 38
Recruitment Details Patients were recruited from institutions including University of North Carolina Hospitals, University of Pittsburgh Medical Center, Mission Cancer Center, and New Bern Cancer Center.
Pre-assignment Details From March 2010 to November 2013, 52 patients consented to treatment. 14 patients were consented and screened for eligibility but found ineligible.
Arm/Group Title Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option
Hide Arm/Group Description

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Period Title: Overall Study
Started 38
Completed 1
Not Completed 37
Reason Not Completed
Adverse Event             15
Withdrawal by Subject             6
Other complicating disease             1
Progression             15
Arm/Group Title Single Arm Trial
Hide Arm/Group Description

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
63.5
(27 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
25
  65.8%
Male
13
  34.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  15.8%
White
30
  78.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
grade 0
18
  47.4%
grade 1
14
  36.8%
not performed
6
  15.8%
[1]
Measure Description:

A scale from 0-5 to describe a patient's level of functioning in terms of selfcare ability and activity level.

0, Fully active

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Never smoker
24
  63.2%
Former light smoker
14
  36.8%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Adenocarcinoma
37
  97.4%
Neuroendocrine carcinoma
1
   2.6%
Previous erlotinib treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
10
  26.3%
Mutation status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
EGFR
6
  15.8%
KRAS
5
  13.2%
EML4/ALK
0
   0.0%
MET del14
1
   2.6%
None (tested and no driver found)
22
  57.9%
Unknown
4
  10.5%
1.Primary Outcome
Title Progression-free Survival
Hide Description Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death
Time Frame 1400 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: months
12.6
(8.0 to 30.5)
2.Secondary Outcome
Title Overall Survival
Hide Description Time of enrollment to date of death.
Time Frame 1400 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: months
20.3
(15.8 to 30.5)
3.Secondary Outcome
Title Subjects Experiencing Toxicity
Hide Description Toxicity will be evaluated using CTCAE criteria, version 3, all grade 3 and 4 events.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received treatment were evaluated
Arm/Group Title Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option
Hide Arm/Group Description:

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
Diarrhea 3
Dyspnea (shortness of breath) 2
Fatigue (asthenia, lethargy, malaise) 6
Hemoglobin 6
Hypertension 6
Leukocytes (total white blood cell count) 2
Lymphopenia 4
Nausea 2
Neutrophils/granulocytes (ANC/AGC) 7
Joint pain 2
Platelets 2
Vomiting 2
Time Frame Five years from registration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Trial
Hide Arm/Group Description

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).

carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)

pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

All-Cause Mortality
Single Arm Trial
Affected / at Risk (%)
Total   28/38 (73.68%) 
Hide Serious Adverse Events
Single Arm Trial
Affected / at Risk (%)
Total   14/38 (36.84%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  2/38 (5.26%) 
Neutrophils/granulocytes (ANC/AGC) * 1  1/38 (2.63%) 
Cardiac disorders   
Left ventricular systolic dysfunction * 1  1/38 (2.63%) 
Supraventricular and nodal arrhythmia - Atrial fibrillation * 1  2/38 (5.26%) 
Gastrointestinal disorders   
Diarrhea * 1  2/38 (5.26%) 
Nausea * 1  1/38 (2.63%) 
General disorders   
Extremity-lower (gait/walking) * 1  1/38 (2.63%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 1  1/38 (2.63%) 
Pain - Pain NOS * 1  1/38 (2.63%) 
Infections and infestations   
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lung (pneumonia) * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS * 1  1/38 (2.63%) 
Infection with unknown ANC - Kidney * 1  1/38 (2.63%) 
Infection with unknown ANC - Lung (pneumonia) * 1  1/38 (2.63%) 
Infection with unknown ANC - Skin (cellulitis) * 1  1/38 (2.63%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/38 (2.63%) 
Nervous system disorders   
Ataxia (incoordination) * 1  1/38 (2.63%) 
Syncope (fainting) * 1  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  3/38 (7.89%) 
Vascular disorders   
Thrombosis/embolism (vascular access-related) * 1  1/38 (2.63%) 
Thrombosis/thrombus/embolism * 1  1/38 (2.63%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Single Arm Trial
Affected / at Risk (%)
Total   38/38 (100.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) * 1  2/38 (5.26%) 
Hemoglobin * 1  19/38 (50.00%) 
Leukocytes (total WBC) * 1  5/38 (13.16%) 
Lymphopenia * 1  6/38 (15.79%) 
Neutrophils/granulocytes (ANC/AGC) * 1  10/38 (26.32%) 
Platelets * 1  7/38 (18.42%) 
Cardiac disorders   
Pericardial effusion (non-malignant) * 1  1/38 (2.63%) 
Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 1  1/38 (2.63%) 
Ear and labyrinth disorders   
Auditory/Ear - Other (Specify, __) * 1  1/38 (2.63%) 
Otitis, external ear (non-infectious) * 1  1/38 (2.63%) 
Tinnitus * 1  1/38 (2.63%) 
Endocrine disorders   
Thyroid function, low (hypothyroidism) * 1  1/38 (2.63%) 
Eye disorders   
Dry eye syndrome * 1  1/38 (2.63%) 
Eyelid dysfunction * 1  1/38 (2.63%) 
Ocular/Visual - Other (Specify, __) * 1  2/38 (5.26%) 
Vision-blurred vision * 1  2/38 (5.26%) 
Watery eye (epiphora, tearing) * 1  3/38 (7.89%) 
Gastrointestinal disorders   
Constipation * 1  14/38 (36.84%) 
Dehydration * 1  1/38 (2.63%) 
Diarrhea * 1  8/38 (21.05%) 
Distension/bloating, abdominal * 1  2/38 (5.26%) 
Dysphagia (difficulty swallowing) * 1  1/38 (2.63%) 
Heartburn/dyspepsia * 1  4/38 (10.53%) 
Hemorrhage, GI - Rectum * 1  2/38 (5.26%) 
Hemorrhoids * 1  2/38 (5.26%) 
Mucositis/stomatitis (clinical exam) - Oral cavity * 1  3/38 (7.89%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity * 1  1/38 (2.63%) 
Nausea * 1  21/38 (55.26%) 
Pain - Abdomen NOS * 1  2/38 (5.26%) 
Pain - Dental/teeth/peridontal * 1  1/38 (2.63%) 
Pain - Intestine * 1  1/38 (2.63%) 
Pain - Oral cavity * 1  1/38 (2.63%) 
Pain - Rectum * 1  2/38 (5.26%) 
Vomiting * 1  9/38 (23.68%) 
General disorders   
Edema: head and neck * 1  1/38 (2.63%) 
Edema: limb * 1  7/38 (18.42%) 
Extremity-lower (gait/walking) * 1  2/38 (5.26%) 
Fatigue (asthenia, lethargy, malaise) * 1  29/38 (76.32%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 1  5/38 (13.16%) 
Flu-like syndrome * 1  1/38 (2.63%) 
Pain - Other (Specify, __) * 1  3/38 (7.89%) 
Pain - Pain NOS * 1  3/38 (7.89%) 
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) * 1  4/38 (10.53%) 
Infections and infestations   
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Abdomen NOS * 1  1/38 (2.63%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lip/perioral * 1  1/38 (2.63%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Upper airway NOS * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Nose * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS * 1  1/38 (2.63%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina * 1  1/38 (2.63%) 
Infection with unknown ANC - Kidney * 1  1/38 (2.63%) 
Infection with unknown ANC - Lung (pneumonia) * 1  1/38 (2.63%) 
Infection with unknown ANC - Middle ear (otitis media) * 1  1/38 (2.63%) 
Infection with unknown ANC - Oral cavity-gums (gingivitis) * 1  1/38 (2.63%) 
Infection with unknown ANC - Skin (cellulitis) * 1  1/38 (2.63%) 
Infection with unknown ANC - Upper airway NOS * 1  1/38 (2.63%) 
Infection with unknown ANC - Urinary tract NOS * 1  1/38 (2.63%) 
Injury, poisoning and procedural complications   
Bruising (in absence of Grade 3 or 4 thrombocytopenia) * 1  1/38 (2.63%) 
Intra-operative injury - Extremity-upper * 1  1/38 (2.63%) 
Intra-operative Injury - Other (Specify, __) * 1  1/38 (2.63%) 
Investigations   
INR (International Normalized Ratio of prothrombin time) * 1  1/38 (2.63%) 
PTT (Partial Thromboplastin Time) * 1  1/38 (2.63%) 
Weight gain * 1  1/38 (2.63%) 
Weight loss * 1  4/38 (10.53%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) * 1  6/38 (15.79%) 
Alkaline phosphatase * 1  3/38 (7.89%) 
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  7/38 (18.42%) 
Anorexia * 1  6/38 (15.79%) 
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  9/38 (23.68%) 
Calcium, serum-high (hypercalcemia) * 1  2/38 (5.26%) 
Cholesterol, serum-high (hypercholesteremia) * 1  1/38 (2.63%) 
Creatinine * 1  5/38 (13.16%) 
Glucose, serum-high (hyperglycemia) * 1  11/38 (28.95%) 
Glucose, serum-low (hypoglycemia) * 1  1/38 (2.63%) 
Magnesium, serum-low (hypomagnesemia) * 1  3/38 (7.89%) 
Potassium, serum-high (hyperkalemia) * 1  3/38 (7.89%) 
Potassium, serum-low (hypokalemia) * 1  4/38 (10.53%) 
Sodium, serum-low (hyponatremia) * 1  5/38 (13.16%) 
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic) * 1  1/38 (2.63%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular * 1  1/38 (2.63%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower * 1  3/38 (7.89%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized * 1  1/38 (2.63%) 
Pain - Back * 1  2/38 (5.26%) 
Pain - Bone * 1  3/38 (7.89%) 
Pain - Chest wall * 1  3/38 (7.89%) 
Pain - Chest/thorax NOS * 1  3/38 (7.89%) 
Pain - Extremity-limb * 1  6/38 (15.79%) 
Pain - Joint * 1  9/38 (23.68%) 
Pain - Muscle * 1  1/38 (2.63%) 
Pain - Neck * 1  1/38 (2.63%) 
Pain - Pelvis * 1  1/38 (2.63%) 
Soft tissue necrosis - Extremity-upper * 1  1/38 (2.63%) 
Nervous system disorders   
Dizziness * 1  8/38 (21.05%) 
Neurology - Other (Specify, __) * 1  1/38 (2.63%) 
Neuropathy: cranial - CN II Vision * 1  1/38 (2.63%) 
Neuropathy: cranial - CN VIII Hearing and balance * 1  1/38 (2.63%) 
Neuropathy: sensory * 1  1/38 (2.63%) 
Pain - Head/headache * 1  9/38 (23.68%) 
Psychiatric disorders   
Confusion * 1  1/38 (2.63%) 
Insomnia * 1  3/38 (7.89%) 
Mood alteration - Depression * 1  5/38 (13.16%) 
Renal and urinary disorders   
Glomerular filtration rate * 1  2/38 (5.26%) 
Pain - Bladder * 1  2/38 (5.26%) 
Urinary frequency/urgency * 1  2/38 (5.26%) 
Urinary retention (including neurogenic bladder) * 1  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders   
Apnea * 1  1/38 (2.63%) 
Cough * 1  7/38 (18.42%) 
Dyspnea (shortness of breath) * 1  7/38 (18.42%) 
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS * 1  4/38 (10.53%) 
Hemorrhage, pulmonary/upper respiratory - Nose * 1  8/38 (21.05%) 
Hiccoughs (hiccups, singultus) * 1  1/38 (2.63%) 
Nasal cavity/paranasal sinus reactions * 1  2/38 (5.26%) 
Pain - Sinus * 1  2/38 (5.26%) 
Pain - Throat/pharynx/larynx * 1  3/38 (7.89%) 
Pleural effusion (non-malignant) * 1  1/38 (2.63%) 
Pneumothorax * 1  1/38 (2.63%) 
Pulmonary/Upper Respiratory - Other (Specify, __) * 1  1/38 (2.63%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) * 1  5/38 (13.16%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify, __) * 1  3/38 (7.89%) 
Hair loss/alopecia (scalp or body) * 1  3/38 (7.89%) 
Hyperpigmentation * 1  3/38 (7.89%) 
Nail changes * 1  1/38 (2.63%) 
Rash/desquamation * 1  3/38 (7.89%) 
Rash: acne/acneiform * 1  4/38 (10.53%) 
Vascular disorders   
Flushing * 1  1/38 (2.63%) 
Hematoma * 1  1/38 (2.63%) 
Hemorrhage/Bleeding - Other (Specify, __) * 1  1/38 (2.63%) 
Hypertension * 1  12/38 (31.58%) 
Hypotension * 1  2/38 (5.26%) 
Phlebitis (including superficial thrombosis) * 1  2/38 (5.26%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
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: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: Robin_V_Johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01344824    
Other Study ID Numbers: LCCC 0825
P30CA016086 ( U.S. NIH Grant/Contract )
First Submitted: April 28, 2011
First Posted: April 29, 2011
Results First Submitted: May 2, 2017
Results First Posted: July 11, 2017
Last Update Posted: October 30, 2017