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Home > "I" Clinical Trials Conditions > Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver  Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
For Condition: recurrent colon cancer,Stage 4 rectal cancer,adenocarcinoma of the rectum,recurrent rectal cancer,childhood gastrointestinal cancer,liver metastases,stage 4 colon cancer,adenocarcinoma of the colon
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal cancer metastatic to the liver.
Details: OBJECTIVES: I. Compare the survival and response rates of patients with colorectal liver metastases treated with intravenous vs. intrahepatic arterial infusion of fluorouracil/leucovorin. II. Assess the effect of these 2 treatments on symptoms and quality of life of these patients. PROTOCOL OUTLINE: Randomized study. Patients randomized to Arm II should have a preoperative hepatic angiography; at laparotomy, an intrahepatic arterial catheter is fused into the gastroduodenal artery to establish an infusion of both lobes of the liver. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Intravenous infusion. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Intrahepatic arterial infusion. PROJECTED ACCRUAL: 312 patients are expected to be randomized within 3-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the colon or rectum with metastases confined to the liver and not amenable to surgery --Prior/Concurrent Therapy-- - No prior fluorouracil (5-FU) for advanced disease; More than 6 months since adjuvant 5-FU (e.g., in AXIS or QUASAR studies) --Patient Characteristics-- - Age: Any age - Performance status: WHO 0-2 - Life expectancy: More than 3 months - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 3.5 mg/dL (50 micromoles/liter) - Renal: Not specified - Cardiovascular: No uncontrolled heart disease (e.g., congestive heart failure, angina) - Other: No uncontrolled infection; No other uncontrolled medical illness
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidKerr, Study Chair, Medical Research Council
University Birmingham
Birmingham, England, B15 2TT
United Kingdom
Additional Information:
Study ID Numbers: CDR0000064434; MRC-CR05,EU-95032
Study Start Date: December 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002692
Other Liver Metastases Studies:
1. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
2. Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum
3. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
4. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
5. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
Related Studies:
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Other England Clinical Trials
Other Birmingham Clinical Trials
Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
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