Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver

NCT00089401 | Completed Phase 2

• 3 other identifiers: 04022904-C-0229CDR0000378323
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 more tumor cells. PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with unresectable colorectal cancer that has metastasized to the liver.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; liver metastases

Outcome Measures

Primary Outcomes (2)

• Response

• Duration of response

Secondary Outcomes (4)

• Patterns of tumor recurrence (liver vs systemic)

• Progression-free survival

• Overall survival

• Quality of life

Interventions

isolated perfusion DRUG

melphalan DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven K. Libutti, MD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: July 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2008
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

US (1)