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Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00402883
Recruitment Status : Terminated (Terminated due to bevacizumab and chemoradiotherapy toxicity)
First Posted : November 22, 2006
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Bevacizumab
Drug: Pemetrexed
Procedure: Radiotherapy
Other: Folic Acid
Other: vitamin B12
Drug: carboplatin
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab
Hide Arm/Group Description

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.

Period Title: Induction Therapy
Started 5
Completed 5
Not Completed 0
Period Title: Consolidation Therapy
Started 5
Completed 5
Not Completed 0
Period Title: Maintenance Therapy
Started 5
Completed 5 [1]
Not Completed 0
[1]
All 5 patients received limited maintenance therapy due to early trial closure.
Arm/Group Title Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  60.0%
>=65 years
2
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
64.6  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.
Arm/Group Title Intervention
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title To Evaluate the Objective Response Rates
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description 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.
All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Intervention
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/5 (20.00%)  1
Cardiac disorders   
Chest Pain  1  1/5 (20.00%)  1
Non-ST elevation acute myocardial infarction  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Difficulty swallowing  1  1/5 (20.00%)  1
Transesophageal fistula  1  2/5 (40.00%)  2
Dislodged PEG tube  1  1/5 (20.00%)  1
Esophagitis  1  1/5 (20.00%)  1
Dehydration  1  1/5 (20.00%)  1
Nausea  1  1/5 (20.00%)  1
Vomiting  1  1/5 (20.00%)  1
General disorders   
Fatigue  1  1/5 (20.00%)  1
Infections and infestations   
Pneumonia  1  2/5 (40.00%)  2
Fever  1  1/5 (20.00%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Shortness of Breath  1  2/5 (40.00%)  3
Hemoptysis  1  1/5 (20.00%)  1
Hypoxemia  1  1/5 (20.00%)  1
Hypoxia  1  1/5 (20.00%)  1
Diffuse infiltrates  1  1/5 (20.00%)  1
COPD exacerbation  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
CO2  1  1/5 (20.00%)  1
Edema (lower extremities)  1  1/5 (20.00%)  2
Hematologic - ANC  1  5/5 (100.00%)  22
Hematologic - Hemoglobin  1  5/5 (100.00%)  39
Hematologic - Platelets  1  5/5 (100.00%)  36
Hematologic - WBC  1  5/5 (100.00%)  39
Hypoxemia  1  2/5 (40.00%)  3
Cardiac disorders   
Tachycardia  1  1/5 (20.00%)  1
Endocrine disorders   
Hot flashes  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Abdominal cramps  1  1/5 (20.00%)  1
Anorexia  1  5/5 (100.00%)  31
Constipation  1  3/5 (60.00%)  8
Dehydration  1  2/5 (40.00%)  5
Diarrhea  1  2/5 (40.00%)  2
Esophageal strictures  1  1/5 (20.00%)  3
Esophagitis  1  5/5 (100.00%)  30
Hematochezia  1  1/5 (20.00%)  1
Hemorrhoid  1  1/5 (20.00%)  1
Hemorrhoidal bleeding  1  1/5 (20.00%)  1
Mucositis  1  1/5 (20.00%)  1
Nausea  1  5/5 (100.00%)  20
Odynophagia  1  1/5 (20.00%)  1
Pain - esophagus  1  3/5 (60.00%)  14
TE fistula  1  2/5 (40.00%)  2
Vomiting  1  4/5 (80.00%)  10
General disorders   
Fatigue  1  5/5 (100.00%)  58
Fever  1  2/5 (40.00%)  2
Weight loss  1  4/5 (80.00%)  34
Immune system disorders   
Allergic Reaction/Hypersensitivity  1  1/5 (20.00%)  1
Infections and infestations   
Infection - sinus  1  1/5 (20.00%)  1
Infection (pneumonia)  1  1/5 (20.00%)  2
Shingles  1  1/5 (20.00%)  4
Metabolism and nutrition disorders   
Alkaline Phosphatase  1  1/5 (20.00%)  2
Gout - R finger  1  1/5 (20.00%)  2
Hyperglycemia  1  4/5 (80.00%)  16
Hypoalbuminemia  1  1/5 (20.00%)  1
Hypocalcemia  1  1/5 (20.00%)  1
Hypokalemia  1  1/5 (20.00%)  9
Hypomagnesemia  1  1/5 (20.00%)  1
Hyponatremia  1  1/5 (20.00%)  1
Proteinuria  1  4/5 (80.00%)  9
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/5 (20.00%)  1
Discomfort (lower back)  1  1/5 (20.00%)  1
Myalgia  1  1/5 (20.00%)  1
Pain - back  1  1/5 (20.00%)  5
Pain - shoulder blades  1  1/5 (20.00%)  1
Nervous system disorders   
Anxiety  1  1/5 (20.00%)  1
Headache  1  1/5 (20.00%)  1
Neuropathy - sensory  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Blood in R nostril in morning  1  1/5 (20.00%)  1
COPD exacerbation  1  1/5 (20.00%)  2
Cough  1  5/5 (100.00%)  14
Dysphagia  1  4/5 (80.00%)  42
Dyspnea  1  4/5 (80.00%)  12
Hemoptysis  1  2/5 (40.00%)  2
Hemorrhage - nose  1  2/5 (40.00%)  3
Interstitial fibrosis  1  1/5 (20.00%)  3
Pain - chest  1  1/5 (20.00%)  1
Pain - mediastinal  1  1/5 (20.00%)  6
Pneumonia  1  1/5 (20.00%)  1
Pulmonary hemorrhage  1  1/5 (20.00%)  1
Shortness of breath  1  1/5 (20.00%)  1
Wheezes  1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/5 (20.00%)  1
Itching  1  1/5 (20.00%)  1
Rash - acneiform (scalp, neck)  1  2/5 (40.00%)  5
Rash - macular (arm)  1  2/5 (40.00%)  5
Rash - Desquamation  1  1/5 (20.00%)  1
Rash - erythema  1  2/5 (40.00%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00402883    
Other Study ID Numbers: SCRI LUN 134
First Submitted: November 21, 2006
First Posted: November 22, 2006
Results First Submitted: August 15, 2013
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014