Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Esophageal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Bevacizumab

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

Erlotinib

Avastin

Daniel Morgensztern, M.D.

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.

Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction

A Phase II Trial of Erlotinib and Avastin in Previously Treated Patients With Cancer of the Esophagus or Gastroesophageal Junction

* 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.

OS is defined as the time from initiation of treatment to the date of death for any reason.

* 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.

Grade 3 and higher toxicities using CTCAE Version 3.0.

Washington University School of Medicine

Erlotinib and Avastin

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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.

Time to Progression (TTP)

Overall Survival Rate (OS)

Complete response

Partial response

Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)

Coagulation: Other, IVC Clot

Death - Disease Progression NOS

Diarrhea

GI: Abdominal hemorrhage, NOS

Pneumonia

Hypernatremia

Confusion

Details of all SAEs and AEs are listed in the Serious Adverse Events and Other Adverse Events modules.

Incidence and Severity of Toxicities

Overall Study

Spots Global Cancer Trial Database for Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial