Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction (OSI3650)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00442507|
Recruitment Status : Terminated (Slow accrual)
First Posted : March 2, 2007
Results First Posted : July 3, 2015
Last Update Posted : July 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms Esophageal Diseases||Drug: Erlotinib Drug: Avastin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Erlotinib and Avastin in Previously Treated Patients With Cancer of the Esophagus or Gastroesophageal Junction|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
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.
Other Name: AvastinDrug: Avastin
- Time to Progression (TTP) [ Time Frame: Median follow-up for TTP 6 weeks (6-18 weeks) ]
- 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.
- Overall Survival Rate (OS) [ Time Frame: 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.
- Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR) [ Time Frame: Median follow-up for response 6 weeks (6-18 weeks) ]
- 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.
- Incidence and Severity of Toxicities [ Time Frame: Median follow-up time for toxicities 72 days (72 days-156 days) ]Grade 3 and higher toxicities using CTCAE Version 3.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442507
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Daniel Morgensztern, M.D.||Washington University School of Medicine|