Isolated Hepatic Perfusion With Melphalan Followed by Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer

NCT00103298 | Completed Phase 2

• 2 other identifiers: CDR0000409754NCI-05-C-0025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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 (1)

• Response and duration of response

Secondary Outcomes (3)

• Patterns of recurrence

• Progression-free and overall survival

• Correlation of health-related quality of life with length of survival

Interventions

FOLFOX regimen DRUG

fluorouracil DRUG

isolated perfusion DRUG

leucovorin calcium DRUG

melphalan DRUG

oxaliplatin DRUG

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 * 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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Leucovorin; Melphalan; Oxaliplatin

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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• H. Richard Alexander, MD, FACS

  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: February 7, 2005
• First Posted: February 8, 2005
• Study Start: December 1, 2004
• Study Completion: July 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2006-02

Locations

US (1)