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A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy


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 treated with isolated hepatic perfusion with melphalan.

Secondary

- Determine the pattern of recurrence (liver vs systemic) in patients treated with this
regimen.

- Determine hepatic progression-free and overall survival in patients treated with this
regimen.

- Determine the time to hepatic and systemic progression in patients treated with this
regimen.

- Determine quality of life (QOL) in patients treated with this regimen.

- Correlate baseline QOL with length of survival in patients treated with this regimen.

OUTLINE: Patients undergo a limited laparotomy to determine if extrahepatic disease that was
not visualized during preoperative scanning is present. Patients found to have peritoneal
seeding or unresectable extrahepatic metastatic disease not previously visualized on scans
do not receive isolated hepatic perfusion (IHP). Remaining patients undergo IHP with
melphalan and hyperthermia therapy. Liver perfusion continues for 1 hour.

Quality of life is assessed at baseline, 6 weeks, and then every 3-4 months for 3 years.

Patients are followed at 6 weeks, every 3-4 months for 3 years, and then every 6 months
thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Safety Issue:

No

Principal Investigator

Steven K. Libutti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

040229

NCT ID:

NCT00089401

Start Date:

July 2004

Completion Date:

March 2008

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182