A Phase II Study of Weekly Oxaliplatin and Irinotecan in the Treatment of Recurrent or Metastatic Esophageal Carcinoma

Inclusion Criteria:

- All patients must have histologically or cytologically confirmed diagnosis of
squamous cell carcinoma or adenocarcinoma of the esophagus. Patients with tumors of
the gastroesophageal junction were eligible if at least 50% of the tumor involved the
esophagus.

- Patients must have locally advanced (i.e. unresectable) or metastatic disease

- All sites of disease must be assessed and designated as measurable or non-measurable
disease as documented by CT, MRI, X-ray physical Each of the criteria in the
following section must be met in order for a patient to be eligible for registration.

- Patients must not have received prior chemotherapy for chemotherapy for advanced or
metastatic esophageal cancer. Chemotherapy given adjuvantly or as a radiosensitizer
is allowed if more than 8 weeks have elapsed since the treatment was completed and
they have recovered from any treatment related toxicity.

- Patients may have received prior radiotherapy if there has been complete recovery
from all radiation-induced toxicities. At least 4 weeks must have been elapsed from
the completion of radiation therapy to the time of registration. If lesions within
the radiation port are to be used to assess response to therapy, those lesions must
have demonstrated clear progression by the criteria outlined in Section 10.2d
following completion of radiation therapy.

- Patients must not have a surgical procedure for esophageal cancer within 4 weeks
prior to registration. Patients must have completely recovered from all surgery prior
to registration.

- All patients must be 18 years of age or older

- Patients must have a Zubrod performance of 0-2

- Patients with any evidence of active or uncontrolled infection, recent myocardial
infection, unstable angina, or life-threatening arrhythmia are not eligible.

- Patients with severe psychiatric disorder are not eligible.

- Patients with known brain metastasis are not eligible. However, brain-imaging studies
are not required for eligibility if the patient has no neurological signs or
symptoms. If brain-imaging studies are performed, they must be negative for disease.

- No other prior malignancy is allowed except for adequately treated basal cell or
squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and
II cancer from which the patient is in complete remission, or any other malignancy
from which the patient has been disease-free for 5 years.

- Patients should not have active infection.

- Patients should not have psychological, familial, sociological, or geographical
conditions that do not permit medical follow-up and compliance with study protocol.

- Except for cancer-related abnormalities, patients should not have unstable or
pre-existing major medical conditions.

- Patients should not have any immediate life-threatening complications of their
malignancies.