Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with internal radiation may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy together with internal radiation works in treating patients with colorectal cancer that has spread to the liver.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Goshen Health System
• Treatments: Calcium; Calcium, Dietary; Camptothecin; Floxuridine; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed colorectal cancer* meeting 1 of the following criteria:

• Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy

• Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy

• Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: *If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated

• Liver-only or liver-predominant disease with any of the following:

• Unresected primary disease

• Limited bone or lung disease

• Potentially resectable nodal disease

• Anastomotic disease

• No active CNS metastasis or diffuse peritoneal metastasis

• No hepatic metastases from a second malignancy

• No predominant extrahepatic disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9 g/dL

• WBC ≥ 1,500/mm^3

• Creatinine ≤ 2 mg/dL

• Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)

• Albumin > 2 g/dL

• INR < 1.5 (without anticoagulation)

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior external-beam radiotherapy to the liver

• Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed