Status:
COMPLETED
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill mor...
Detailed Description
OBJECTIVES: Primary * Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed colorectal cancer
- Metastatic disease limited to the parenchyma of the liver
- Patients with limited sites of extrahepatic disease AND who have dominant life-limiting disease in the liver are considered eligible provided the extrahepatic sites can be treated with local ablative measures (e.g., resection or external beam radiotherapy)
- No other evidence of unresectable extrahepatic disease by radiological studies
- Unresectable hepatic disease defined by \> 3 sites of disease in the liver, bilobar disease, or tumor abutting major vascular or ductal structures making anatomic resection with liver function preservation impossible
- Measurable disease
- Refractory to prior first-line systemic chemotherapy
- Disease progression during or after completion of treatment with an irinotecan- or oxaliplatin-containing regimen for established hepatic metastases
- Treatment failure is defined as disease progression evidenced by tumor growth OR new lesions on imaging modalities OR increasing carcinoembryonic antigen (CEA)
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Hematocrit \> 27.0%
- Platelet count \> 100,000/mm\^3
- WBC \> 3,000/mm\^3
- Hepatic
- Bilirubin \< 2.0 mg/dL
- PT ≤ 2 seconds of the upper limit of normal
- ALT and AST elevations secondary to metastatic disease allowed
- Chronic active hepatitis B or C allowed provided there is no evidence of cirrhosis on pathology, radiologic studies, or physical exam
- No history of veno-occlusive disease
- No biopsy proven cirrhosis
- No evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system
- No other liver condition that would preclude study therapy
- Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance \> 60 mL/min
- Cardiovascular
- LVEF ≥ 40%
- No ischemic cardiac disease
- No history of congestive heart failure
- Pulmonary
- Chronic obstructive pulmonary disease or other chronic pulmonary disease allowed provided pulmonary function test ≥ 50% of predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
- Weight \> 30 kg
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 4 weeks since prior biologic therapy for the malignancy and recovered
- Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy for the malignancy and recovered
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy for the malignancy and recovered
- Surgery
- See Disease Characteristics
- Other
- No concurrent immunosuppressive drugs
- No concurrent chronic anticoagulation therapy
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00089401
Start Date
July 1 2004
End Date
March 1 2008
Last Update
May 14 2012
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182