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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

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