Trial Outcomes & Findings for Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00438204)
NCT ID: NCT00438204
Last Updated: 2021-04-13
Results Overview
RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2021-04-13
Participant Flow
Participant milestones
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 Participants
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsRECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 Participants
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Progression-free Survival (PFS)
|
6.1 months
Interval 3.9 to 7.6
|
SECONDARY outcome
Timeframe: Every 8 weeks, for up to 54 monthsThe rate of response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 Participants
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Number of Participants With Response
Not response evaluable
|
1 Participants
|
|
Number of Participants With Response
Complete response
|
1 Participants
|
|
Number of Participants With Response
Partial response
|
15 Participants
|
|
Number of Participants With Response
Stable disease
|
12 Participants
|
|
Number of Participants With Response
Progressive disease
|
10 Participants
|
SECONDARY outcome
Timeframe: Every two weeks, for up to 54 monthsGrade 3/4 toxicity according to the NCI Common Toxicity Criteria v3.0 .
Outcome measures
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 Participants
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Febrile Neutropenia
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Elevated ALT/AST
|
4 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Neutropenia
|
11 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Leukopenia
|
3 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Anemia
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Thrombocytopenia
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Acute renal insufficiency
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Anorexia
|
2 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Thrombosis/embolism
|
3 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Dehydration
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Fatigue
|
7 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Hyperglycemia
|
9 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Hypertension
|
2 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Nausea/vomiting
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Bowel Perforation
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Dyspnea
|
4 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Diverticulitis
|
2 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity
Ataxia
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 8 weeks, for up to 54 monthsTime to treatment failure using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 Participants
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Time to Treatment Failure
|
6.2 months
Interval 3.9 to 8.0
|
SECONDARY outcome
Timeframe: Every 8 weeks, for up to 54 monthsOverall survival using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 Participants
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Overall Survival
|
17.5 months
Interval 8.4 to 28.0
|
Adverse Events
Bevacizumab, Gemcitabine Hydrochloride
Serious events: 18 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 participants at risk
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Investigations
Neutrophils
|
28.2%
11/39 • Number of events 11 • Approximately 7 years
|
|
Investigations
White blood cells (WBC)
|
7.7%
3/39 • Number of events 3 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Investigations
Platelet count decreased
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Investigations
Lymphocyte count decreased
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
4/39 • Number of events 4 • Approximately 7 years
|
|
Renal and urinary disorders
Acute renal insufficiency
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
General disorders
Fatigue
|
17.9%
7/39 • Number of events 7 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
9/39 • Number of events 9 • Approximately 7 years
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hypophospatemia
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness-generalized
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Gastrointestinal disorders
Bowel Perforation
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Infections and infestations
Right otitis media
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
General disorders
Fever
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.3%
4/39 • Number of events 4 • Approximately 7 years
|
|
Gastrointestinal disorders
Perforation
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
General disorders
Pain
|
7.7%
3/39 • Number of events 3 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Gastrointestinal disorders
Diverticulitis
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
Gout
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Neutropenia
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Infections and infestations
Otitis media
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Investigations
Pancytopenia
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Vascular disorders
Pulmonary Embolism
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Right side pleural effusion
|
2.6%
1/39 • Number of events 1 • Approximately 7 years
|
Other adverse events
| Measure |
Bevacizumab, Gemcitabine Hydrochloride
n=39 participants at risk
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
|
|---|---|
|
Investigations
WBC
|
53.8%
21/39 • Number of events 21 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Hgb
|
82.1%
32/39 • Number of events 32 • Approximately 7 years
|
|
Investigations
ANC
|
30.8%
12/39 • Number of events 12 • Approximately 7 years
|
|
Investigations
Platelets
|
7.7%
3/39 • Number of events 3 • Approximately 7 years
|
|
General disorders
Fatigue
|
61.5%
24/39 • Number of events 24 • Approximately 7 years
|
|
General disorders
Fever
|
23.1%
9/39 • Number of events 9 • Approximately 7 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
6/39 • Number of events 6 • Approximately 7 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
13/39 • Number of events 13 • Approximately 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
9/39 • Number of events 9 • Approximately 7 years
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
6/39 • Number of events 6 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
12/39 • Number of events 12 • Approximately 7 years
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
33.3%
13/39 • Number of events 13 • Approximately 7 years
|
|
Investigations
Alanine Aminotransferase (ALT) increased
|
35.9%
14/39 • Number of events 14 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
61.5%
24/39 • Number of events 24 • Approximately 7 years
|
|
Vascular disorders
Hypertension
|
28.2%
11/39 • Number of events 11 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness-generalized
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Gastrointestinal disorders
Nausea
|
25.6%
10/39 • Number of events 10 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.5%
8/39 • Number of events 8 • Approximately 7 years
|
|
Investigations
Alkaline Phosphotase increased
|
12.8%
5/39 • Number of events 5 • Approximately 7 years
|
|
Investigations
Creatinine increased
|
10.3%
4/39 • Number of events 4 • Approximately 7 years
|
|
Renal and urinary disorders
Proteinuria
|
25.6%
10/39 • Number of events 10 • Approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
Fluid retention syndrome (FRS)
|
23.1%
9/39 • Number of events 9 • Approximately 7 years
|
|
General disorders
Pain
|
35.9%
14/39 • Number of events 14 • Approximately 7 years
|
|
Infections and infestations
Infrection systemic
|
15.4%
6/39 • Number of events 6 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung hemorrhage
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.1%
2/39 • Number of events 2 • Approximately 7 years
|
Additional Information
Antionette J. Wozniak, M.D., F.A.C.P.
Barbara Ann Karmanos Cancer Institute
Phone: (313)576-8752
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place