First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
Study Details
Study Description
Brief Summary
This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small cell lung cancer. The primary objective in this study is to see how well this combination of drugs keeps the cancer from getting worse in this elderly population of non-small cell lung cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Patients in this study will be assigned to one of 2 treatment groups. The selection of the treatment groups will be done randomly by a computer.
The first group, Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
The second group, Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
In both regimens vitamin B12 injections and Folic Acid pills will be given to reduce the occurrence of side effects from the treatment.
Each patient's disease will be evaluated at intervals by the proper scans or X-rays to see how well the cancer is responding to the treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. |
Drug: Pemetrexed
pemetrexed 500 mg/m2
Other Names:
Drug: Gemcitabine
gemcitabine 1500 mg/m2
Other Names:
Drug: Bevacizumab
bevacizumab 10mg/kg bevacizumab 15mg/kg
Other Names:
|
| Experimental: Cohort B Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. |
Drug: Pemetrexed
pemetrexed 500 mg/m2
Other Names:
Drug: Bevacizumab
bevacizumab 10mg/kg bevacizumab 15mg/kg
Other Names:
Drug: Carboplatin
carboplatin AUC=5
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months]
Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.
Secondary Outcome Measures
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [From date of treatment initiation to end of study treatment up to 18 months]
Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [From date of study entry until the date of death from any cause or the date the patient was last known alive, up to 18 months]
OS is defined as the time from the date of study entry until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to the last date the participant was known to be alive.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed non-small cell bronchogenic carcinoma, (adenocarcinoma, or large cell carcinoma)
-
Patients who have newly diagnosed unresectable stage III or stage IV disease are eligible.
-
Must be at least 70 years of age
-
Must have measurable disease by CT scan
-
Must be able to be up and about and care for themselves
-
May not have received prior treatment for stage III or IV disease
-
Must have adequate white and red blood cells and platelets.
-
Must be able to take Vitamin B12, Folic Acid and dexamethasone as stated in the study
-
Must be able to understand the nature of this study and give written informed consent
-
Adequate liver and kidney function
Exclusion Criteria:
-
Past or current history of cancer with the exception of treated non- melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and have been disease free for five years
-
Female patients who are pregnant or are lactating are ineligible
-
History of unstable angina or myocardial infarction within 6 months prior to beginning bevacizumab
-
Brain metastasis - cancer that has spread to the brain
-
Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study
-
Full-dose oral or by vein anticoagulation or receiving anti-clotting therapy within 10 days of starting treatment
-
Serious nonhealing wound, ulcer, or bone fracture
-
Bleeding or clotting disorders
-
Uncontrolled high blood pressure or serious heart arrhythmia requiring medication
-
History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to beginning bevacizumab
-
Chronic non-steroidal anti-inflammatory use is not allowed on study
-
History of stroke or TIAs within the last 6 months
Please Note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northeast Alabama Regional Medical Center | Anniston | Alabama | United States | 36207 |
| 2 | NEA Baptist Clinic | Jonesboro | Arkansas | United States | 72401 |
| 3 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 4 | Watson Clinic Center for Cancer Care and Research | Lakeland | Florida | United States | 33805 |
| 5 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
| 6 | Wellstar Cancer Research | Marietta | Georgia | United States | 30060 |
| 7 | Providence Medical Group | Terre Haute | Indiana | United States | 47802 |
| 8 | Graves-Gilbert Clinic | Bowling Green | Kentucky | United States | 42101 |
| 9 | Consultants in Blood Disorders and Cancer | Louisville | Kentucky | United States | 40207 |
| 10 | Mercy Hospital | Portland | Maine | United States | 04101 |
| 11 | Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
| 12 | Methodist Cancer Center | Omaha | Nebraska | United States | 68114 |
| 13 | Cancer Care of Western North Carolina | Asheville | North Carolina | United States | 28801 |
| 14 | Oncology Hematology Care | Cincinnati | Ohio | United States | 45242 |
| 15 | Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 16 | Associates in Hematology Oncology | Chattanooga | Tennessee | United States | 37404 |
| 17 | Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | United States | 37404 |
| 18 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37023 |
Sponsors and Collaborators
- SCRI Development Innovations, LLC
- Genentech, Inc.
- Eli Lilly and Company
Investigators
- Principal Investigator: David R Spigel, MD, SCRI Development Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
- SCRI LUN 139
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|
| Arm/Group Description | Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. | Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. |
| Period Title: Combination Therapy | ||
| STARTED | 55 | 55 |
| COMPLETED | 3 | 29 |
| NOT COMPLETED | 52 | 26 |
| Period Title: Combination Therapy | ||
| STARTED | 3 | 29 |
| COMPLETED | 3 | 29 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin | Total |
|---|---|---|---|
| Arm/Group Description | Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. | Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. | Total of all reporting groups |
| Overall Participants | 55 | 55 | 110 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
76
|
77
|
77
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
47.3%
|
29
52.7%
|
55
50%
|
| Male |
29
52.7%
|
26
47.3%
|
55
50%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
55
100%
|
55
100%
|
110
100%
|
Outcome Measures
| Title | Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease |
|---|---|
| Description | Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions. |
| Time Frame | From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were analyzed for a response by RECIST v1.0. Intent to treat efficacy analysis set. |
| Arm/Group Title | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|
| Arm/Group Description | Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. | Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. |
| Measure Participants | 55 | 55 |
| Median (95% Confidence Interval) [months] |
4.7
|
10.2
|
| Title | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
|---|---|
| Description | Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters) |
| Time Frame | From date of treatment initiation to end of study treatment up to 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were analyzed for a response by RECIST v1.0. Intent to treat analysis set. |
| Arm/Group Title | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|
| Arm/Group Description | Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. | Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. |
| Measure Participants | 55 | 55 |
| Number (95% Confidence Interval) [percentage of patients] |
35
|
35
|
| Title | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
|---|---|
| Description | OS is defined as the time from the date of study entry until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to the last date the participant was known to be alive. |
| Time Frame | From date of study entry until the date of death from any cause or the date the patient was last known alive, up to 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were included in the analysis. Intent to treat analysis set. |
| Arm/Group Title | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|
| Arm/Group Description | Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. | Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. |
| Measure Participants | 55 | 55 |
| Number (95% Confidence Interval) [months] |
7.5
|
14.8
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin | ||
| Arm/Group Description | Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen. | Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen. | ||
All Cause Mortality |
||||
| Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 33/55 (60%) | 21/55 (38.2%) | ||
| Blood and lymphatic system disorders | ||||
| Platelets | 1/55 (1.8%) | 1 | 1/55 (1.8%) | 1 |
| Hemoglobin | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Leukocytes | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Cardiac disorders | ||||
| Hypertension | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Cardiopulmonary Arrest | 1/55 (1.8%) | 1 | 1/55 (1.8%) | 1 |
| Ventricular Arrhythmia - Ventricular Tachycardia | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Supraventricular arrhythmia - Atrial fibrillation | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Cardiac Ischemia/Infarction | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Gastrointestinal disorders | ||||
| Ileus | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Perforation - Diverticulum | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Perforation - duodenal ulcer | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pain - rectum | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| GI Other - strangulated inguinal hernia | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Vomiting | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Dehydration | 1/55 (1.8%) | 1 | 2/55 (3.6%) | 2 |
| Ulcer - stomach | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| General disorders | ||||
| Multi-system Organ Failure | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Fever | 1/55 (1.8%) | 1 | 1/55 (1.8%) | 1 |
| Fatigue | 2/55 (3.6%) | 2 | 0/55 (0%) | 0 |
| Pain - Abdomen | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Pain - joint | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Dysphagia | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Consitutional symptoms, other - failure to thrive | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Immune system disorders | ||||
| Neutrophils | 3/55 (5.5%) | 3 | 0/55 (0%) | 0 |
| Infections and infestations | ||||
| Infection - Sepsis | 2/55 (3.6%) | 2 | 0/55 (0%) | 0 |
| Febrile neutropenia | 2/55 (3.6%) | 2 | 1/55 (1.8%) | 1 |
| Infection - Pneumonia | 7/55 (12.7%) | 8 | 1/55 (1.8%) | 1 |
| Infection - gangrene | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Infection - cellulitis | 2/55 (3.6%) | 2 | 0/55 (0%) | 0 |
| Infection with Normal ANC | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Infection - methicillin-resistant staphylococcus aureas | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Infection - urinary tract | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Hyponatremia | 0/55 (0%) | 0 | 2/55 (3.6%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Death - disease progression NOS | 2/55 (3.6%) | 2 | 2/55 (3.6%) | 2 |
| Disease progression NOS | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Nervous system disorders | ||||
| CNS Cerebrovascular ischemia | 2/55 (3.6%) | 2 | 1/55 (1.8%) | 1 |
| Confusion | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
| Renal and urinary disorders | ||||
| Obstruction, GU - Bladder | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hemorrhage - Pulmonary | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pulmonary - COPD Exacerbation | 1/55 (1.8%) | 1 | 2/55 (3.6%) | 3 |
| Dyspnea | 3/55 (5.5%) | 3 | 3/55 (5.5%) | 4 |
| Pneumothorax | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pleural Effusion | 2/55 (3.6%) | 2 | 0/55 (0%) | 0 |
| ARDS | 1/55 (1.8%) | 1 | 1/55 (1.8%) | 1 |
| Hypoxia | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pericardial Effusion | 0/55 (0%) | 0 | 1/55 (1.8%) | 1 |
| Vascular disorders | ||||
| Thrombosis/Thrombus/Embolism | 3/55 (5.5%) | 3 | 1/55 (1.8%) | 1 |
| Aneurysm | 1/55 (1.8%) | 1 | 0/55 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 55/55 (100%) | 55/55 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Edema - Limb | 16/55 (29.1%) | 33 | 10/55 (18.2%) | 26 |
| Neutrophils | 39/55 (70.9%) | 84 | 42/55 (76.4%) | 118 |
| Hemoglobin | 45/55 (81.8%) | 128 | 45/55 (81.8%) | 243 |
| Platelets | 30/55 (54.5%) | 55 | 40/55 (72.7%) | 153 |
| Leukocytes | 39/55 (70.9%) | 89 | 47/55 (85.5%) | 151 |
| Hemorrhage - Nose | 10/55 (18.2%) | 21 | 15/55 (27.3%) | 26 |
| INR | 3/55 (5.5%) | 3 | 0/55 (0%) | 0 |
| Cardiac disorders | ||||
| Hypertension | 7/55 (12.7%) | 13 | 18/55 (32.7%) | 42 |
| Hypotension | 3/55 (5.5%) | 3 | 0/55 (0%) | 0 |
| Eye disorders | ||||
| Dry Eye | 3/55 (5.5%) | 4 | 0/55 (0%) | 0 |
| Watery Eye | 0/55 (0%) | 0 | 5/55 (9.1%) | 15 |
| Gastrointestinal disorders | ||||
| Anorexia | 25/55 (45.5%) | 55 | 26/55 (47.3%) | 65 |
| Constipation | 21/55 (38.2%) | 34 | 22/55 (40%) | 77 |
| Dehydration | 14/55 (25.5%) | 18 | 8/55 (14.5%) | 16 |
| Diarrhea | 14/55 (25.5%) | 22 | 19/55 (34.5%) | 40 |
| Dysphagia | 0/55 (0%) | 0 | 4/55 (7.3%) | 9 |
| Mucositis/Stomatitis | 6/55 (10.9%) | 8 | 11/55 (20%) | 20 |
| Nausea | 29/55 (52.7%) | 46 | 29/55 (52.7%) | 66 |
| Taste Alteration | 5/55 (9.1%) | 8 | 12/55 (21.8%) | 40 |
| Vomiting | 6/55 (10.9%) | 7 | 13/55 (23.6%) | 18 |
| General disorders | ||||
| Fatigue | 46/55 (83.6%) | 158 | 48/55 (87.3%) | 298 |
| Fever | 16/55 (29.1%) | 17 | 3/55 (5.5%) | 3 |
| Pain - Head | 8/55 (14.5%) | 10 | 14/55 (25.5%) | 41 |
| Insomnia | 10/55 (18.2%) | 19 | 7/55 (12.7%) | 12 |
| Pain - NOS | 0/55 (0%) | 0 | 4/55 (7.3%) | 14 |
| Pain - Abdomen | 7/55 (12.7%) | 17 | 4/55 (7.3%) | 5 |
| Pain - Back | 0/55 (0%) | 0 | 4/55 (7.3%) | 6 |
| Pain - Bone | 0/55 (0%) | 0 | 3/55 (5.5%) | 5 |
| Pain - Chest | 4/55 (7.3%) | 5 | 11/55 (20%) | 23 |
| Pain - Limb | 4/55 (7.3%) | 4 | 6/55 (10.9%) | 12 |
| Pain - Mouth | 3/55 (5.5%) | 9 | 3/55 (5.5%) | 9 |
| Pain - Neck | 0/55 (0%) | 0 | 3/55 (5.5%) | 9 |
| Rigor/Chills | 7/55 (12.7%) | 13 | 0/55 (0%) | 0 |
| Voice Changes | 0/55 (0%) | 0 | 9/55 (16.4%) | 36 |
| Infections and infestations | ||||
| Febrile Neutropenia | 4/55 (7.3%) | 4 | 0/55 (0%) | 0 |
| Infection - NOS | 30/55 (54.5%) | 61 | 17/55 (30.9%) | 31 |
| Metabolism and nutrition disorders | ||||
| Alkaline Phosphatase | 9/55 (16.4%) | 13 | 6/55 (10.9%) | 11 |
| ALT | 10/55 (18.2%) | 17 | 5/55 (9.1%) | 7 |
| AST | 13/55 (23.6%) | 27 | 7/55 (12.7%) | 7 |
| Creatinine | 3/55 (5.5%) | 5 | 8/55 (14.5%) | 11 |
| Hypercalcemia | 0/55 (0%) | 0 | 4/55 (7.3%) | 6 |
| Hyperglycemia | 15/55 (27.3%) | 28 | 15/55 (27.3%) | 32 |
| Hyperkalemia | 0/55 (0%) | 0 | 6/55 (10.9%) | 18 |
| Hypoalbuminemia | 11/55 (20%) | 19 | 9/55 (16.4%) | 21 |
| Hypocalcemia | 7/55 (12.7%) | 9 | 4/55 (7.3%) | 7 |
| Hypoglycemia | 0/55 (0%) | 0 | 15/55 (27.3%) | 32 |
| Hypokalemia | 3/55 (5.5%) | 4 | 6/55 (10.9%) | 14 |
| Hyponatremia | 7/55 (12.7%) | 18 | 10/55 (18.2%) | 14 |
| Weight Loss | 9/55 (16.4%) | 15 | 9/55 (16.4%) | 29 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 5/55 (9.1%) | 12 | 14/55 (25.5%) | 33 |
| Muscle Weakness | 0/55 (0%) | 0 | 4/55 (7.3%) | 4 |
| Myalgia | 6/55 (10.9%) | 7 | 18/55 (32.7%) | 35 |
| Nervous system disorders | ||||
| Confusion | 5/55 (9.1%) | 7 | 0/55 (0%) | 0 |
| Dizziness | 11/55 (20%) | 16 | 16/55 (29.1%) | 22 |
| Neuropathy - Sensory | 5/55 (9.1%) | 10 | 4/55 (7.3%) | 5 |
| Psychiatric disorders | ||||
| Mood Alteration - Anxiety | 4/55 (7.3%) | 4 | 3/55 (5.5%) | 7 |
| Mood Alteration - Depression | 3/55 (5.5%) | 5 | 4/55 (7.3%) | 14 |
| Renal and urinary disorders | ||||
| Proteinuria | 22/55 (40%) | 42 | 28/55 (50.9%) | 119 |
| Urinary Retention | 0/55 (0%) | 0 | 3/55 (5.5%) | 6 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Rhinitis | 0/55 (0%) | 0 | 9/55 (16.4%) | 34 |
| Bronchospasm | 3/55 (5.5%) | 5 | 7/55 (12.7%) | 12 |
| Cough | 21/55 (38.2%) | 36 | 20/55 (36.4%) | 68 |
| Dyspnea | 34/55 (61.8%) | 69 | 29/55 (52.7%) | 109 |
| Respiratary - Other | 4/55 (7.3%) | 5 | 0/55 (0%) | 0 |
| Voice Changes | 0/55 (0%) | 0 | 5/55 (9.1%) | 8 |
| Hypoxia | 4/55 (7.3%) | 6 | 0/55 (0%) | 0 |
| Nasal/Paranasal Reactions | 9/55 (16.4%) | 20 | 3/55 (5.5%) | 9 |
| Pulmonary - COPD Exacerbation | 4/55 (7.3%) | 5 | 0/55 (0%) | 0 |
| ARDS | 3/55 (5.5%) | 3 | 0/55 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 4/55 (7.3%) | 5 | 6/55 (10.9%) | 17 |
| Dermatology - Other | 0/55 (0%) | 0 | 3/55 (5.5%) | 4 |
| Dry Skin | 4/55 (7.3%) | 6 | 0/55 (0%) | 0 |
| Erythema | 3/55 (5.5%) | 3 | 5/55 (9.1%) | 7 |
| Pruritis | 4/55 (7.3%) | 4 | 5/55 (9.1%) | 6 |
| Rash/Desquamation | 15/55 (27.3%) | 25 | 16/55 (29.1%) | 32 |
| Vascular disorders | ||||
| Thrombosis/Thrombus/Embolism | 6/55 (10.9%) | 10 | 4/55 (7.3%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
| Name/Title | John Hainsworth, MD |
|---|---|
| Organization | Sarah Cannon Research Institute |
| Phone | 1-877-691-7274 |
| asksarah@scresearch.net |
- SCRI LUN 139