Phase 2 N=62 Treatment

Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

Esophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00393068 ↗

Enrolled (actual)

Serious AEs

61.3%

Results posted

Nov 2012

Primary outcome: Primary: Pathologic Complete Response (pCR) Rate — 18 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib (Drug); Bevacizumab (Drug); Paclitaxel (Drug); Carboplatin (Drug); 5-FU (Drug); Radiation therapy (Procedure); Surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SCRI Development Innovations, LLC
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Pathologic Complete Response (pCR) Rate	18	—
SECONDARY Overall Survival	30.16	—
SECONDARY Progression-Free Survival	28.58	—

Summary

The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. Side effects (toxicity) information will also be collected.

Eligibility Criteria

Inclusion Criteria

Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III
No prior treatment for esophageal cancer
Must be surgical candidate based on stage and location of disease
Measurable or evaluable disease
Able to be up and perform self care
Adequate liver, renal function and bone marrow function
Patients will have to have a central venous access device placed
Able to give written informed consent.
Age 18 or older

Exclusion Criteria

Stage IV disease
Prior cancer treatment for advanced cancer in the last 5 years
Pregnant or lactating women
History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
History of neurological disease
Recent history of blood in the sputum or vomitus
Non-healing wounds, ulcer or long bone fractures
History of bleeding problems or coagulation problems
History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
History of uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00393068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.