RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery. PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

Condition	Treatment or Intervention	Phase
Pancreatic Cancer Gastric Cancer Colorectal Cancer Colon Cancer	Procedure: supportive care  Behavior: supportive care/therapy  Procedure: quality-of-life assessment  Drug: bowel obstruction management	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents. II. Evaluate the efficacy and safety of this treatment in these patients. III. Evaluate the quality of life of these patients after enteral Wallstent placement.

PROTOCOL OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum. Quality of life is assessed at 48 hours and 6 months after procedure. Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Endoscopically confirmed localized tumor as the cause of duodenal obstruction

• All primary tumor types are eligible

No prior duodenal Wallstents

Must have symptoms of gastrointestinal obstruction, including:

• Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: Prior or concurrent chemotherapy allowed

Endocrine therapy: Not specified

Radiotherapy: Prior or concurrent radiotherapy allowed

Surgery: At least 3 weeks since prior surgery and recovered

--Patient Characteristics--

Age: 18 and over

Performance status: ECOG 0-3

Life expectancy: Not specified

Hematopoietic: Platelet count greater than 50,000/mm3

Hepatic: INR no greater than 1.5 times upper limit of normal

Renal: Not specified

Cardiovascular: No cardiac condition

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) that would preclude endoscopy
• No other serious concurrent illness
• No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism)
• No dementia, psychiatric disorder, or altered mental status that would preclude compliance
• History of other neoplastic disease allowed
• Veterans Administration patients are not eligible

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States

Study chairs or principal investigators

Willis Parsons, III,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067590; NU-98CC2; NCI-G00-1703
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004910
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08