NCT00032123
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
PHASE2
COMPLETED
NCT00032123
INTERVENTIONAL
A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
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.
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
Esophageal Cancer
Gastric Cancer
- TREATMENT
-
- Type: DRUG
- Name: erlotinib hydrochloride
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network