Trial Outcomes & Findings for Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (NCT NCT00402883)
NCT ID: NCT00402883
Last Updated: 2021-11-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
18 months
Results posted on
2021-11-09
Participant Flow
Participant milestones
| Measure |
Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.
Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
|
|---|---|
|
Induction Therapy
STARTED
|
5
|
|
Induction Therapy
COMPLETED
|
5
|
|
Induction Therapy
NOT COMPLETED
|
0
|
|
Consolidation Therapy
STARTED
|
5
|
|
Consolidation Therapy
COMPLETED
|
5
|
|
Consolidation Therapy
NOT COMPLETED
|
0
|
|
Maintenance Therapy
STARTED
|
5
|
|
Maintenance Therapy
COMPLETED
|
5
|
|
Maintenance Therapy
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab
n=5 Participants
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.
The objective benefit is defined as substantial shrinkage in tumor volume per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and is assessed by MRI or CT. Objective response = complete response + partial response. Complete Response (CR) is defined as the Disappearance of all target lesions; Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.
Overall survival was defined as the interval between the date of study entry until the date of death
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=5 participants at risk
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
|
|---|---|
|
Cardiac disorders
Chest Pain
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
40.0%
2/5 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
40.0%
2/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Difficulty swallowing
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Transesophageal fistula
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Dislodged PEG tube
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Non-ST elevation acute myocardial infarction
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Fever
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse infiltrates
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Intervention
n=5 participants at risk
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal cramps
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
20.0%
1/5 • Number of events 2
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
5/5 • Number of events 31
|
|
Nervous system disorders
Anxiety
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Blood in R nostril in morning
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
CO2
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
20.0%
1/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
5/5 • Number of events 14
|
|
Gastrointestinal disorders
Dehydration
|
40.0%
2/5 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Discomfort (lower back)
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
80.0%
4/5 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
80.0%
4/5 • Number of events 12
|
|
Blood and lymphatic system disorders
Edema (lower extremities)
|
20.0%
1/5 • Number of events 2
|
|
Gastrointestinal disorders
Esophageal strictures
|
20.0%
1/5 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
100.0%
5/5 • Number of events 30
|
|
General disorders
Fatigue
|
100.0%
5/5 • Number of events 58
|
|
General disorders
Fever
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout - R finger
|
20.0%
1/5 • Number of events 2
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Hematochezia
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematologic - ANC
|
100.0%
5/5 • Number of events 22
|
|
Blood and lymphatic system disorders
Hematologic - Hemoglobin
|
100.0%
5/5 • Number of events 39
|
|
Blood and lymphatic system disorders
Hematologic - Platelets
|
100.0%
5/5 • Number of events 36
|
|
Blood and lymphatic system disorders
Hematologic - WBC
|
100.0%
5/5 • Number of events 39
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
40.0%
2/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage - nose
|
40.0%
2/5 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhoid
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoidal bleeding
|
20.0%
1/5 • Number of events 1
|
|
Endocrine disorders
Hot flashes
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
80.0%
4/5 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypoxemia
|
40.0%
2/5 • Number of events 3
|
|
Infections and infestations
Infection - sinus
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection (pneumonia)
|
20.0%
1/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial fibrosis
|
20.0%
1/5 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Itching
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 20
|
|
Nervous system disorders
Neuropathy - sensory
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Odynophagia
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
20.0%
1/5 • Number of events 5
|
|
Gastrointestinal disorders
Pain - esophagus
|
60.0%
3/5 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Pain - shoulder blades
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - chest
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - mediastinal
|
20.0%
1/5 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Proteinuria
|
80.0%
4/5 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - acneiform (scalp, neck)
|
40.0%
2/5 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash - macular (arm)
|
40.0%
2/5 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash - Desquamation
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - erythema
|
40.0%
2/5 • Number of events 8
|
|
Infections and infestations
Shingles
|
20.0%
1/5 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
TE fistula
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
4/5 • Number of events 10
|
|
General disorders
Weight loss
|
80.0%
4/5 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Wheezes
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER