Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00032123

SWOG-S0127

CDR0000069259

Details and patient eligibility

About

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction.

Full description

OBJECTIVES:

• Determine the overall response rate of patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with erlotinib. (Gastric stratum temporarily closed to accrual as of 03/01/2003.)
• Determine the frequency and severity of toxic effects of this drug in these patients.
• Determine the overall survival and time to treatment failure in patients treated with this drug.
• Determine the value of intratumoral expression of epidermal growth factor receptor in predicting patient response to this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to cancer site (stomach vs gastroesophageal junction). (The gastric stratum is temporarily closed to accrual as of 03-01-2003.)

Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 14-40 months. (The gastric stratum is temporarily closed to accrual as of 03-01-2003.)

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the stomach* or gastroesophageal (GE) junction

  • GE junction tumors include esophageal tumors arising 5 cm from the anatomic GE junction or in the gastric cardia
  • Locally advanced (i.e., unresectable) or metastatic disease NOTE: *Gastric stratum temporarily closed to accrual as of 03/01/2003

• Unidimensionally measurable disease

  • Target lesion must not be in previously irradiated field unless there is documentation of clear progression

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 2 times ULN

Cardiovascular:

• No recent myocardial infarction
• No unstable angina
• No life-threatening arrhythmia

Gastrointestinal:

• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• No active peptic ulcer disease
• Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
• No intractable nausea or vomiting

Ophthalmic:

• No history of corneal disease, including:

  • Dry eye syndrome or Sjögren's syndrome
  • Keratoconjunctivitis sicca
  • Exposure keratopathy
  • Fuch's dystrophy
  • Other active disorders of the cornea

Other:

• HIV negative
• No active or uncontrolled infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• No severe psychiatric disorders
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy
• No concurrent anticancer immunotherapy

Chemotherapy:

• No prior chemotherapy for advanced or metastatic gastric cancer
• At least 8 weeks since prior adjuvant chemotherapy or chemotherapy given as a radiosensitizer and recovered
• No concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent anticancer radiotherapy

Surgery:

• At least 4 weeks since prior surgical procedure for stomach* or GE cancer and recovered
• No prior surgical procedures that would affect absorption NOTE: *Gastric stratum temporarily closed to accrual as of 03/01/2003

Other:

• No prior investigational drugs
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapy