Rectal Cancer
Conditions
Brief summary
The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.
Interventions
DRUGTNFerade™
Sponsors
GenVec
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 \</= 1.0 mg/dL; AST/ALT \>/= 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
Countries
United States
Outcome results
None listed