Clinical trial NCT00137878: TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Lead sponsor: GenVec
Sponsor class: INDUSTRY
First posted: 2005-08-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Center for Cancer Research, NCI
state: Maryland
Study officials:
References: