Trial Outcomes & Findings for Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction (NCT NCT00442507)
NCT ID: NCT00442507
Last Updated: 2015-07-24
Results Overview
* TTP is defined as the time from initiation of treatment to the date of documented progression. * The median of TTP with 95% confidence interval will be presented. * Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. * Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions.
TERMINATED
PHASE2
6 participants
Median follow-up for TTP 6 weeks (6-18 weeks)
2015-07-24
Participant Flow
The study opened to participant accrual on 03/16/2007 and closed to participant accrual on 01/21/2009.
Participant milestones
| Measure |
Erlotinib and Avastin
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction
Baseline characteristics by cohort
| Measure |
Erlotinib and Avastin
n=6 Participants
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
|
|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median follow-up for TTP 6 weeks (6-18 weeks)Population: 1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.
* TTP is defined as the time from initiation of treatment to the date of documented progression. * The median of TTP with 95% confidence interval will be presented. * Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. * Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Erlotinib and Avastin
n=5 Participants
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
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|---|---|
|
Time to Progression (TTP)
|
4.2 months
Interval 1.4 to 13.4
|
SECONDARY outcome
Timeframe: Median followup time from completion of treatment 325.5 days (44-401 days)OS is defined as the time from initiation of treatment to the date of death for any reason.
Outcome measures
| Measure |
Erlotinib and Avastin
n=6 Participants
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
|
|---|---|
|
Overall Survival Rate (OS)
|
10.7 months
Interval 1.4 to 13.1
|
SECONDARY outcome
Timeframe: Median follow-up for response 6 weeks (6-18 weeks)Population: 1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.
* CR = disappearance of all target lesions * PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Erlotinib and Avastin
n=5 Participants
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
|
|---|---|
|
Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)
Complete response
|
0 participants
|
|
Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)
Partial response
|
0 participants
|
SECONDARY outcome
Timeframe: Median follow-up time for toxicities 72 days (72 days-156 days)Population: Details of all SAEs and AEs are listed in the Serious Adverse Events and Other Adverse Events modules.
Grade 3 and higher toxicities using CTCAE Version 3.0.
Outcome measures
| Measure |
Erlotinib and Avastin
n=6 Participants
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
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|---|---|
|
Incidence and Severity of Toxicities
Coagulation: Other, IVC Clot
|
1 participants
|
|
Incidence and Severity of Toxicities
Death - Disease Progression NOS
|
1 participants
|
|
Incidence and Severity of Toxicities
Diarrhea
|
1 participants
|
|
Incidence and Severity of Toxicities
GI: Abdominal hemorrhage, NOS
|
1 participants
|
|
Incidence and Severity of Toxicities
Pneumonia
|
1 participants
|
|
Incidence and Severity of Toxicities
Hypernatremia
|
1 participants
|
|
Incidence and Severity of Toxicities
Confusion
|
1 participants
|
Adverse Events
Erlotinib and Avastin
Serious adverse events
| Measure |
Erlotinib and Avastin
n=6 participants at risk
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
|
|---|---|
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Gastrointestinal disorders
Dehydration
|
33.3%
2/6
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6
|
|
Nervous system disorders
Confusion
|
16.7%
1/6
|
|
General disorders
Death - Disease Progression NOS
|
16.7%
1/6
|
|
Cardiac disorders
Coagulation: Other, IVC Clot
|
16.7%
1/6
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6
|
|
Infections and infestations
C. difficile colitis
|
33.3%
2/6
|
Other adverse events
| Measure |
Erlotinib and Avastin
n=6 participants at risk
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
|
|---|---|
|
Cardiac disorders
Atrial flutter
|
16.7%
1/6
|
|
Vascular disorders
Hypertension
|
16.7%
1/6
|
|
General disorders
Chills
|
16.7%
1/6
|
|
General disorders
Fatigue
|
33.3%
2/6
|
|
General disorders
Sweating
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
83.3%
5/6
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
16.7%
1/6
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6
|
|
Gastrointestinal disorders
Stenosis
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
16.7%
1/6
|
|
Investigations
Lymphopenia
|
33.3%
2/6
|
|
Investigations
Platelets
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Bilirubin
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
16.7%
1/6
|
|
Gastrointestinal disorders
GI: Abdomenal hemorrhage NOS
|
16.7%
1/6
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
33.3%
2/6
|
|
Nervous system disorders
Confusion
|
16.7%
1/6
|
|
Nervous system disorders
Cerebrovascular ischemia
|
16.7%
1/6
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6
|
|
Psychiatric disorders
Mood alteration - depression
|
16.7%
1/6
|
|
Nervous system disorders
Neuropathy
|
16.7%
1/6
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6
|
|
Cardiac disorders
Chest pain
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
16.7%
1/6
|
|
Gastrointestinal disorders
Esophagus pain
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
16.7%
1/6
|
|
Investigations
Creatinine
|
16.7%
1/6
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6
|
Additional Information
Daniel Morgensztern, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place