A Phase II Randomized Trial Comparing TNFerade™ Biologic With Capecitabine and Radiation Therapy Followed by Surgical Resection Versus Capecitabine and Radiation Therapy Followed by Surgical Resection for the Treatment of Rectal Cancer

Inclusion Criteria:

- All patients who have biopsy proven T3 or T4 rectal cancer which is confined to the
primary tumor site with or without regional lymph node involvement

- Patients must be willing to return for follow-up

- Patients must be able to give and sign informed consent

- Patients must be suitable candidates for surgical resection post-chemoradiation, i.e.
no history of severe congestive heart failure or severe pulmonary disease

- Life expectancy > 6 months

Exclusion Criteria:

- Patients with evidence of distant metastatic disease

- Any of the following hematologic abnormalities: hemoglobin (HGB) < 8.0 gm/dL unable
to be corrected with a transfusion; absolute neutrophil count (ANC) < 1500 cells/mm3;
platelets < 100,000/mm3; activated partial thromboplastin time (APTT) ratio or
International Normalized Ratio (INR) > 1.5 (except in patients who are
therapeutically anticoagulated for non-related medical conditions such as atrial
fibrillation and whose anti-thrombotic treatment cannot be withheld for vector
injection or surgery).

- A history of hepatic cirrhosis or present hepatic dysfunction with total bilirubin >
2.0 mg/dL except for patients with Gilbert's syndrome who must have a direct
bilirubin /= 2.5 times upper limit of normal.

- Renal insufficiency as determined by a serum creatinine > 2.0 mg/dL

- Patients may not have received prior therapy with chemotherapy, biologic therapy or
radiation therapy for rectal cancer

- Significant history of a medical problem that would preclude the patient from
undergoing an operative procedure such as a history of severe congestive heart
failure or active ischemic heart disease

- Concurrent second malignancy requiring systemic therapy

- Pregnant or lactating women

- Chronic systemic corticosteroid use

- Prior surgery for rectal cancer

- Patients with history of deep venous thrombosis or pulmonary embolism

- Patients with Doppler evidence of deep venous thrombosis at screening

- Known history of documented coagulopathy or thrombophilic disorders

- Hormone replacement therapy within one month prior to Day 1

- Known history of documented cerebrovascular disease, stroke or transient ischemic
attack (TIA)

- Surgery within the last one month, excluding diverting colostomy or ileostomy for
obstruction