TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

This study has been completed.
Sponsor:
Information provided by:
GenVec
ClinicalTrials.gov Identifier:
NCT00137878
First received: August 26, 2005
Last updated: February 22, 2012
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Drug: TNFerade™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GenVec:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137878

Locations
United States, Maryland
Center for Cancer Research, NCI
Bethesda, Maryland, United States
Sponsors and Collaborators
GenVec
  More Information

Additional Information:
No publications provided

Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov Identifier: NCT00137878     History of Changes
Obsolete Identifiers: NCT00069147, NCT00072241
Other Study ID Numbers: GV-001.007
Study First Received: August 26, 2005
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014