Status:
COMPLETED
Isolated Hepatic Perfusion With Melphalan Followed by Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
Lead Sponsor:
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, leucovorin, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppin...
Detailed Description
OBJECTIVES: Primary * Determine the response and duration of response in patients with previously untreated unresectable liver metastases secondary to colorectal cancer treated with isolated hepatic...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed colorectal cancer
- Metastatic disease limited to the parenchyma of the liver
- No evidence of unresectable extrahepatic disease by preoperative radiology
- Limited extra-hepatic disease and dominant life-limiting liver disease allowed provided extra-hepatic sites are treatable by local ablative measures (e.g., surgical resection or external beam radiotherapy)
- At least 40% hepatic replacement by tumor by axial CT scan or MRI
- Unresectable liver metastases, defined by 1 of the following:
- More than 3 sites of disease in the liver
- Bilobar disease
- Tumor abutting major vascular or ductal structures
- Measurable disease
- Previously untreated disease
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Hematocrit \> 27.0%
- WBC \> 3,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 2.0 mg/dL
- PT \< 2 seconds above upper limit of normal
- Elevated transaminase levels allowed if due to liver metastases
- No cirrhosis by biopsy
- No significant portal hypertension as manifested by any of the following:
- Ascites
- Esophageal varices by endoscopy
- Significant collateral vessels around the organs drained by the portal venous system by radiography
- No chronic active hepatitis
- Hepatitis B and C surface antigen negative
- No history of veno-occlusive disease
- Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance \> 60 mL/min
- Cardiovascular
- No ischemic cardiac disease
- No history of congestive heart failure
- LVEF \> 40% by echocardiogram or stress thallium scan (for patients with cardiac disease)
- Pulmonary
- No chronic obstructive pulmonary disease or other chronic pulmonary disease
- Pulmonary function tests ≥ 50% of predicted (for patients with pulmonary disease)
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight \> 30 kg
- No active infection
- No peripheral neuropathy ≥ grade 2
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Prior adjuvant chemotherapy (including leucovorin calcium, oxaliplatin, and fluorouracil) allowed provided it was administered \> 6 months before liver metastases were diagnosed
- Endocrine therapy
- Not specified
- Radiotherapy
- More than 4 weeks since prior radiotherapy for this malignancy and recovered
- Surgery
- Not specified
- Other
- No concurrent chronic anticoagulation therapy
- No concurrent immunosuppressive drugs
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00103298
Start Date
December 1 2004
End Date
July 1 2006
Last Update
June 20 2013
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182