NCT00103298CompletedPhase 2
A Phase II Trial of Isolated Hepatic Perfusion (IHP) and Systemic FOLFOX4 for Subjects With Metastatic Unresectable Colorectal Cancers of the Liver With ≥ 40% Hepatic Tumor Burden
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 2
- Primary Endpoint
- Response and duration of response
Study Overview
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 stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan followed by combination chemotherapy works in treating patients with unresectable liver metastases from colorectal cancer.
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 perfusion with melphalan followed by leucovorin calcium, oxaliplatin, and fluorouracil.
Secondary
- Determine the patterns of recurrence (liver vs systemic) in patients treated with this regimen.
- Determine progression-free and overall survival of patients treated with this regimen.
- Correlate health-related quality of life with length of survival of patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hematocrit > 27.0%
- •WBC > 3,000/mm^3
- •Platelet count > 100,000/mm^3
- •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:
- •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
- •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)
- •No chronic obstructive pulmonary disease or other chronic pulmonary disease
- •Pulmonary function tests ≥ 50% of predicted (for patients with pulmonary disease)
- •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
- +7 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response and duration of response
Secondary Outcomes
- Patterns of recurrence
- Progression-free and overall survival
- Correlation of health-related quality of life with length of survival
Investigators
Study Sites (2)
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