TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137878
• Other study ID #: GV-001.007
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2005
• Last updated: February 22, 2012

Study information

• Verified date: May 2011
• Source: GenVec
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00069147
• NCT00072241

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• TNFerade™

Locations

Country	Name	City	State
United States	Center for Cancer Research, NCI	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
GenVec

Country where clinical trial is conducted

United States, 

External Links

•   PubMed.gov