Trial Outcomes & Findings for A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE) (NCT NCT00403403)
NCT ID: NCT00403403
Last Updated: 2011-04-29
Results Overview
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Randomization until progression or lost to follow-up (up to 2 years)
Results posted on
2011-04-29
Participant Flow
Participant milestones
| Measure |
Placebo+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
Safety-Evaluable Patients
|
47
|
51
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Baseline characteristics by cohort
| Measure |
Placebo+Chemotherapy
n=50 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=52 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until progression or lost to follow-up (up to 2 years)Population: Intent-to-treat population
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Outcome measures
| Measure |
Placebo+Chemotherapy
n=50 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=52 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
4.4 Months
Interval 4.2 to 4.9
|
5.5 Months
Interval 4.5 to 6.7
|
SECONDARY outcome
Timeframe: Randomization until death or lost of follow-up (up to 27 months)Population: Intent-to-treat population
Duration of overall survival from randomization until death or loss to follow-up
Outcome measures
| Measure |
Placebo+Chemotherapy
n=50 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=52 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Overall Survival
|
10.9 Months
Interval 8.1 to 14.7
|
9.4 Months
Interval 8.7 to 11.3
|
SECONDARY outcome
Timeframe: Randomization until progression or lost to follow-up (up to 2 years)Population: Intent-to-treat population
Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
Outcome measures
| Measure |
Placebo+Chemotherapy
n=50 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=52 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Percentage of Participants With an Objective Response
|
48.0 Percentage of participants
|
57.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Randomization until progression or lost to follow-up (up to 2 years)Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart. Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
Outcome measures
| Measure |
Placebo+Chemotherapy
n=50 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=52 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Number of Participants With an Objective Response
|
24 number of participants
|
30 number of participants
|
SECONDARY outcome
Timeframe: Randomization until progression or lost to follow-up (up to 2 years)Population: Randomized patients with measurable disease at baseline.
Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Outcome measures
| Measure |
Placebo+Chemotherapy
n=24 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=30 Participants
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Duration of Objective Response
|
3.2 Months
Interval 2.9 to 4.2
|
4.7 Months
Interval 4.2 to 5.8
|
Adverse Events
Placebo+Chemotherapy
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Bevacizumab+Chemotherapy
Serious events: 20 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo+Chemotherapy
n=47 participants at risk
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=51 participants at risk
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.3%
2/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
3.9%
2/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
3.9%
2/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
3.9%
2/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
General disorders
Death
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Infections and infestations
Pneumonia
|
4.3%
2/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
5.9%
3/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Infections and infestations
Lobar Pneumonia
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Investigations
Hemoglobin Decreased
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Renal and urinary disorders
Renal Failure
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
3.9%
2/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.3%
2/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
2.0%
1/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.1%
1/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
0.00%
0/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
Other adverse events
| Measure |
Placebo+Chemotherapy
n=47 participants at risk
Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
Bevacizumab+Chemotherapy
n=51 participants at risk
Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
42.6%
20/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
39.2%
20/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
2/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
7.8%
4/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
|
Vascular disorders
Hypertension
|
25.5%
12/47 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
29.4%
15/51 • Overall duration of study
Safety analyses were performed on the safety evaluable population, which included 98 patients who received at least one dose of chemotherapy, bevacizumab, or placebo. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER