Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction

• GE junction tumors with 50% or more tumor located in the esophagus determined by radiologic or endoscopic evaluation

• Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen

• Stage IVB disease allowed if metastases to distant regional lymph nodes (celiac or cervical) only and no other sites

• Not a surgical candidate and ineligible for chemotherapy due to any of the following:

• Neuropathy

• Cardiac disease

• Performance status 2

• General overall condition felt by the investigator to be a contraindication to platinum-based therapy

• Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors

• No evidence of clinically active interstitial lung disease (patients who are asymptomatic with chronic, stable, radiographic lung changes allowed)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 4 months

• WBC ≥ 3,000/mm³

• ANC ≥ 1,500/mm³

• Platelet count > 100,000/mm³

• Bilirubin ≤ 1.3 mg/dL

• ALT and AST ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• No prior malignancies except basal cell or squamous cell skin cancer, in situ cervical cancer, or superficial transitional cell bladder cancer, unless diagnosed and/or treated > 2 years prior to current study and are without evidence of recurrence

• No history of allergy to erlotinib or any of its excipients

• No serious, uncontrolled, concurrent infection

• No clinically serious, uncontrolled medical conditions that the investigator feels might compromise study participation

• No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome

• No unwillingness to participate or inability to comply with the protocol for the duration of the study

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for this tumor

• No prior resection or attempted resection of esophageal cancer

• No prior anti-epidermal growth factor receptor therapy (unless given in an adjuvant setting and completed at least 12 months earlier)

• No participation in any investigational drug study within the past 4 weeks

• No HIV-positive patients receiving antiretroviral therapy

• No concurrent CYP3A4/5 inducers or inhibitors