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TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137878
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : February 23, 2012
Sponsor:
Information provided by:
GenVec

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: TNFerade™ Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137878


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

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Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov Identifier: NCT00137878    
Obsolete Identifiers: NCT00069147, NCT00072241
Other Study ID Numbers: GV-001.007
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: May 2011
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases