An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Renal cell cancer (RCC)

- Prior nephrectomy required

- Prostate cancer

- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)

- Failed prior hormonal therapy (e.g., antiandrogen, luteinizing
hormone-releasing hormone inhibitor, or orchiectomy)

- Pancreatic cancer

- Failed at least 1 prior standard therapy regimen for unresectable
metastatic disease

- Non-small cell lung cancer

- Failed at least 1 prior standard therapy regimen for unresectable
metastatic disease

- Colorectal cancer

- Received 1 or more prior chemotherapy regimen(s) for advanced metastatic
disease

- Esophageal cancer

- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)

- Gastroesophageal junction cancer

- Evaluable disease

- Epidermal growth factor receptor overexpression

- Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of
evaluated tumor cells

- No uncontrolled brain metastases

- No evidence of disease progression or regression after a 30-day washout period

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100% OR

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver
metastases)

- Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)

Renal:

- Creatinine less than 2.2 mg/dL

- NCI renal toxicity no greater than grade 2

- No hypercalcemia (antihypercalcemic therapy allowed)

Cardiovascular:

- Ejection fraction at least 45% by MUGA

- No abnormal ECG or MUGA

- No myocardial infarction within the past year

Pulmonary:

- No abnormal chest x-ray

- FEV_1 greater than 50% of predicted

Other:

- No known allergy to ingredients of study drug

- No known allergy to Staphylococcus aureus Protein A

- HIV negative

- No chronic medical or psychiatric condition that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or
co-stimulatory pathway inhibitors)

- No other concurrent biologic therapy

Chemotherapy:

- See Disease Characteristics

- At least 6 weeks since prior chemotherapy and recovered

- No prior chemotherapy for RCC

- No prior anthracyclines

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- Concurrent steroids allowed

- Concurrent hormonal therapy allowed

Radiotherapy:

- See Disease Characteristics

- No prior mediastinal radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from any recent prior surgery

Other:

- At least 30 days since prior investigational drug or device

- At least 30 days since prior systemic therapy

- No other concurrent investigational drugs

- No other concurrent systemic agents or cancer therapy