Trial Outcomes & Findings for Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00234052)
NCT ID: NCT00234052
Last Updated: 2019-06-04
Results Overview
Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
Results posted on
2019-06-04
Participant Flow
The study opened for accrual on June 1, 2005 with an accrual goal of 50 patients. The first patient enrolled started treatment on July 28, 2005. The study was closed permanently on July 10, 2007 when accrual had been met with 51 patients registered and 50 patients treated on study.
Participant milestones
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Treatment
STARTED
|
51
|
|
Treatment
Started Treatment
|
50
|
|
Treatment
Completed 6 Cycles
|
33
|
|
Treatment
Went Into Maintenance Phase
|
30
|
|
Treatment
COMPLETED
|
30
|
|
Treatment
NOT COMPLETED
|
21
|
|
Follow-up for 5 Years
STARTED
|
50
|
|
Follow-up for 5 Years
COMPLETED
|
1
|
|
Follow-up for 5 Years
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Treatment
Withdrawal by Subject
|
3
|
|
Treatment
Adverse Event
|
5
|
|
Treatment
Death
|
2
|
|
Treatment
Progressive Disease
|
11
|
|
Follow-up for 5 Years
Death
|
41
|
|
Follow-up for 5 Years
Lost to Follow-up
|
1
|
|
Follow-up for 5 Years
Other
|
7
|
Baseline Characteristics
Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=51 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Median Progression Free Survival
|
7.8 Months
Interval 5.2 to 11.5
|
SECONDARY outcome
Timeframe: Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)Population: One patient received less than one cycle and was determined to not be evaluable for this outcome measure.
Overall Response Rate (ORR) of patients treated with carboplatin, pemetrexed, and bevacizumab combination is defined as the number of patients who's best response is a Complete Response (CR) plus Partial Response (PR)as recorded from the start of treatment until disease progression as assessed by RECIST 1.0. CR=Disappearance of all target lesions for a minimum of 4 weeks. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions for a minimum of 4 weeks, taking as reference the baseline sum LD. No simultaneous increase in the size of any lesion or the appearance of a new lesion may occur.
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=49 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Overall Response Rate
|
27 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)Population: This includes AEs observed before there was an amendment of the protocol to exclude patients with histories of diverticulitis or clinically significant diverticular disease. Any patient that received one dose of study drug is evaluable for this objective.
To characterize the toxicity profile of carboplatin, pemetrexed and bevacizumab combination treatment. Toxicity data will be collected from initiation of treatment, every cycle, until 30 days post last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). Only toxicity determined to be a least possibility related to at least one study drug and grade 3 or 4 was collected for this outcome measure. In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Anemia
|
3 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Thrombocytopenia
|
4 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Neutropenia
|
2 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Venous Thrombosis
|
3 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Fatigue
|
4 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Diverticulitis
|
4 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Infection
|
5 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Proteinuria
|
1 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Arterial Thrombosis
|
1 Participants
|
|
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Increased Creatinine Levels
|
1 Participants
|
SECONDARY outcome
Timeframe: During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined from the time of registration to the study until death from any cause. Patients that are lost to follow up will be censored from last documentation of survival status.
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Overall Survival Rate
|
14.1 Months
Interval 10.6 to 19.6
|
SECONDARY outcome
Timeframe: From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.Population: Patients with response were included in this outcome measure.
Duration of Response for patients treated with the combination of carboplatin, pemetrexed and bevacizumab is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date of documented progressive disease.
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=27 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Duration of Response
|
7.7 Months
Interval 4.4 to 12.5
|
POST_HOC outcome
Timeframe: 6, 12,18, and 24 months from treatment initiationPopulation: One patient received less than one cycle and was determined to not be evaluable for this objective.
Progression Free Survival (PFS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined as the percentage of patients without progression at the following time points from registration to the study: 6 months 12 months 18 months 24 months.
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Progression Free Survival at 6, 12, 18, 24 Months
6 Months
|
59 percentage of patients with PFS
|
|
Progression Free Survival at 6, 12, 18, 24 Months
12 Months
|
34 percentage of patients with PFS
|
|
Progression Free Survival at 6, 12, 18, 24 Months
18 Months
|
27 percentage of patients with PFS
|
|
Progression Free Survival at 6, 12, 18, 24 Months
24 Months
|
19 percentage of patients with PFS
|
POST_HOC outcome
Timeframe: 6, 12,18, and 24 months from treatment initiationOverall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment will be defined as the percentage of patients with documentation of status of alive at the following timepoints from registration to the study: 6 months 12 months 18 months 24 months
Outcome measures
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 Participants
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Overall Survival Rate at 6, 12, 18, and 24 Months
6 Months
|
86 percentage of patients alive
|
|
Overall Survival Rate at 6, 12, 18, and 24 Months
12 Months
|
61 percentage of patients alive
|
|
Overall Survival Rate at 6, 12, 18, and 24 Months
18 Months
|
38 percentage of patients alive
|
|
Overall Survival Rate at 6, 12, 18, and 24 Months
24 Months
|
26 percentage of patients alive
|
Adverse Events
Treatment With Carboplatin + Pemetrexed + Bevacizumab
Serious events: 22 serious events
Other events: 50 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 participants at risk
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Puesdogout
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Cardiac disorders
Heart Attack
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Cardiac disorders
Cardiomyopathy
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Acute and Chronic Cholelithiasis
|
4.0%
2/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Diverticulitis
|
8.0%
4/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Epistaxis
|
4.0%
2/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Infections and infestations
Osteomylitis of the right great toe
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Infections and infestations
Axillary Abscess
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Nervous system disorders
Seizures
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Infections and infestations
Viral Pneumonitis resulting in Death
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Infections and infestations
Pneumonia/death
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
2/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.0%
1/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
Other adverse events
| Measure |
Treatment With Carboplatin + Pemetrexed + Bevacizumab
n=50 participants at risk
Carboplatin + Pemetrexed + Bevacizumab
Patients will receive 6 cycles where (1 cycle is 21 days) of :
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Carboplatin: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
Patients without progression will go into the maintenance phase and receive cycles of the following where 1 cycle is 21 days:
Bevacizumab: 15 mg/kg administered intravenously over 30 - 90 minutes on day 1 of each cycle Pemetrexed: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils (Neutropenia)
|
12.0%
6/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Blood and lymphatic system disorders
Hemoglobin (Anemia)
|
60.0%
30/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Blood and lymphatic system disorders
Leukocytes (Total white blood cells)
|
18.0%
9/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Blood and lymphatic system disorders
Platelets (Thrombocytopenia)
|
22.0%
11/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Cardiac disorders
Hypertension
|
40.0%
20/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Albumin Decrease
|
10.0%
5/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Fatigue
|
86.0%
43/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Creatinine, Serum-high
|
18.0%
9/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Calcium, Serum-low (Hypocalcemia)
|
6.0%
3/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Glucose, Serum-high (Hyperglycemia)
|
36.0%
18/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Fever
|
8.0%
4/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Insomnia
|
6.0%
3/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Weight Loss
|
20.0%
10/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
12.0%
6/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Anorexia
|
14.0%
7/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
15/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
12/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
26.0%
13/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Nausea
|
44.0%
22/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
11/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Epistaxis (Nosebleed)
|
16.0%
8/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Renal and urinary disorders
Urinary Tract Infection NOS
|
6.0%
3/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Infections and infestations
Infection NOS
|
8.0%
4/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Alkaline Phosphastase Increase
|
16.0%
8/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Transaminase
|
12.0%
6/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
ALT Increase
|
8.0%
4/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
AST Increase
|
10.0%
5/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Metabolism and nutrition disorders
Proteinuria
|
8.0%
4/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Nervous system disorders
Neuropathy: Sensory
|
10.0%
5/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Nervous system disorders
Dizziness
|
6.0%
3/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
10.0%
5/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
4/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Nervous system disorders
Headache
|
18.0%
9/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
General disorders
Pain NOS
|
50.0%
25/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
5/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of Breath)
|
48.0%
24/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
|
Eye disorders
Watery Eye
|
6.0%
3/50 • Adverse events were collected from the start of treatment, every cycle, until 30 days post the last treatment where one cycle equals 21 days. Range of cycles completed by patients = 1 cycle to 51 cycles.
|
Additional Information
Clinical Trials Office
Northwestern University
Phone: 312-695-1301
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place