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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020501 |
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 and giving them in different ways may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Metastatic Cancer |
Drug: FOLFIRI regimen Drug: floxuridine Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: melphalan Procedure: hyperthermia treatment |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Prospective Random Assignment Trial of Regional and Systemic Chemotherapy With or Without Initial Isolated Hepatic Perfusion for Patients With Metastatic Unresectable Colorectal Cancers of the Liver |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to prior chemotherapy for liver metastasis (yes vs no) and percentage of hepatic replacement (less than 25% vs at least 25%). All patients undergo laparotomy to determine final eligibility. Eligible patients are randomized to 1 of 2 treatment arms.
Treatment with combined systemic and local chemotherapy repeats every 35 days for a maximum of 6 courses. Treatment with local chemotherapy alone repeats every 28 days for a maximum of 6 additional courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, postoperatively, every third course of chemotherapy, every 3 months for 2 years, and then every 6 months thereafter.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 168 patients (84 per treatment arm) will be accrued for this study within 54 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver
Unresectable liver metastasis, as defined by the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
No active chronic hepatitis
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | H. Richard Alexander, MD, FACS | NCI - Surgery Branch |
Study ID Numbers: | CDR0000068562, NCI-01-C-0093 |
Study First Received: | July 11, 2001 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00020501 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
Melphalan Digestive System Neoplasms Floxuridine Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Liver neoplasms Leucovorin Intestinal Diseases Rectal Diseases Camptothecin |
Recurrence Intestinal Neoplasms Rectal neoplasm Liver Neoplasms Calcium, Dietary Digestive System Diseases Fluorouracil Neoplasm Metastasis Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Vitamin B Complex Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Vitamins Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Micronutrients Antineoplastic Agents, Phytogenic Alkylating Agents |