A Phase 2 interventional study of Erlotinib and Avastin in Esophageal Neoplasms and Esophageal Diseases, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-24.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
Determine the time to progression for the combination of erlotinib and bevacizumab in patients with previously treated metastatic cancer of the esophagus or gastroesophageal junction
We postulate that the addition of bevacizumab may increase the efficacy of erlotinib in patients with metastatic esophageal cancer, without adding significant toxicity. The non-overlapping toxicity profiles may allow the administration of the maximum tolerated doses for both agents without additive toxicities with the goal of demonstrating synergistic clinical activity. This combination has been previously tested in two studies for other malignancies with good tolerance and encouraging results.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 6 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate hepatic and renal function, defined as:
Exclusion Criteria:
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.
Drug: Erlotinib · Drug: Avastin
Also known as: Avastin
Time to Progression (TTP)
* 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.
Time frame: Median follow-up for TTP 6 weeks (6-18 weeks)
Overall Survival Rate (OS)
OS is defined as the time from initiation of treatment to the date of death for any reason.
Time frame: Median followup time from completion of treatment 325.5 days (44-401 days)
Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)
* 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.
Time frame: Median follow-up for response 6 weeks (6-18 weeks)
Incidence and Severity of Toxicities
Grade 3 and higher toxicities using CTCAE Version 3.0.
Time frame: Median follow-up time for toxicities 72 days (72 days-156 days)
The study opened to participant accrual on 03/16/2007 and closed to participant accrual on 01/21/2009.
| Milestone | Erlotinib and Avastin |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
* 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.
| months | Erlotinib and Avastin |
|---|---|
| Time to Progression (TTP) | 4.2 (1.4 to 13.4) |
OS is defined as the time from initiation of treatment to the date of death for any reason.
| months | Erlotinib and Avastin |
|---|---|
| Overall Survival Rate (OS) | 10.7 (1.4 to 13.1) |
* 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.
| participants | Erlotinib and Avastin |
|---|---|
| Complete response | 0 |
| Partial response | 0 |
Grade 3 and higher toxicities using CTCAE Version 3.0.
| participants | Erlotinib and Avastin |
|---|---|
| Coagulation: Other, IVC Clot | 1 |
| Death - Disease Progression NOS | 1 |
| Diarrhea | 1 |
| GI: Abdominal hemorrhage, NOS | 1 |
| Pneumonia | 1 |
| Hypernatremia | 1 |
| Confusion | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib and Avastin | — | 2/6 (33.3%) | 6/6 (100%) |
| Event | Erlotinib and Avastin |
|---|---|
| DehydrationGastrointestinal disorders | 2/6 |
| DiarrheaGastrointestinal disorders | 2/6 |
| C. difficile colitisInfections and infestations | 2/6 |
| ConfusionNervous system disorders | 1/6 |
| Death - Disease Progression NOSGeneral disorders | 1/6 |
| Coagulation: Other, IVC ClotCardiac disorders | 1/6 |
| PneumoniaInfections and infestations | 1/6 |
| Event | Erlotinib and Avastin |
|---|---|
| RashSkin and subcutaneous tissue disorders | 5/6 |
| NauseaGastrointestinal disorders | 4/6 |
| FatigueGeneral disorders | 2/6 |
| AnorexiaMetabolism and nutrition disorders | 2/6 |
| VomitingGastrointestinal disorders | 2/6 |
| LymphopeniaInvestigations | 2/6 |
| Urinary tract infectionInfections and infestations | 2/6 |
| HyperkalemiaMetabolism and nutrition disorders | 2/6 |
| Alkaline phosphataseMetabolism and nutrition disorders | 2/6 |
| DizzinessNervous system disorders | 2/6 |
| Age, Continuous(years) | Erlotinib and Avastin |
|---|---|
| Median | 63.5 (42 to 67) |
| Sex: Female, Male(Participants) | Erlotinib and Avastin |
|---|---|
| Female | 1 |
| Male | 5 |
| Region of Enrollment(participants) | Erlotinib and Avastin |
|---|---|
| United States | 6 |
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine