Phase 2 N=22 Treatment

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

Esophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00524121 ↗

Enrolled (actual)

Serious AEs

52.9%

Results posted

Mar 2015

Primary outcome: Primary: Overall Survival — 7.3 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: erlotinib hydrochloride (Drug); immunohistochemistry staining method (Other); radiation therapy (Radiation)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Roswell Park Cancer Institute
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	7.3	—
SECONDARY Complete Response	11.76	—
SECONDARY Progresssion-Free Survival	4.5	—
SECONDARY Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale	1.05; 1.36	0.011 sig
SECONDARY Correlation of Smoking Status With Overall Survival	2.4; 7.2; 16.6	0.115
SECONDARY Response by Epidermal Growth Factor Receptor (EGFR) Expression	6; 5; 2; 3	1.000
SECONDARY Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression	5; 6; 3; 2	1.000
SECONDARY Response by EGFR Mutation Status	9; 2; 3; 2	0.5467

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00524121). 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.