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A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver Clinical research trials and A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver. A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver clinical trial. Human subjects frequently get the finest healthcare available for their A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver  A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver
A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver
For Condition: Colorectal Neoplasm,Liver Neoplasm,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with unresectable colorectal cancer confined to the liver will undergo a 60 minute hyperthermic isolated hepatic perfusion with melphalan. Postoperatively, patients will be treated with hepatic arterial infusion (HAI) of floxuridine (FUDR), and leucovorin as a 2 week continuous infusion regimen given every 28 days. The continuous infusion will also contain dexamethasone, if patients receive the HAI through an implantable infusion pump. Response to treatment, duration of response, patterns of failure and survival and quality of life will be followed.
Details: Patients with unresectable colorectal cancer confined to the liver will undergo a 60 minute hyperthermic isolated hepatic perfusion with melphalan. Postoperatively, patients will be treated with hepatic arterial infusion (HAI) of floxuridine (FUDR), and leucovorin as a 2 week continuous infusion regimen given every 28 days. The continuous infusion will also contain dexamethasone, if patients receive the HAI through an implantable infusion pump. Response to treatment, duration of response, patterns of failure and survival and quality of life will be followed.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies. Limited resectable extrahepatic disease is acceptable. Patients previously treated with intrahepatic artery infusional therapy using FUDR will be excluded. Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects. Patients must have an ECOG performance standard of 0, 1, or 2 for 24 hours prior to surgery and then again 24 hours prior to post perfusion chemotherapy, as well. Patients must have adequate hepatic function as evidenced by bilirubin less than 2.0 mg/dL and a PT less than or equal to 2 seconds of the upper limit of normal. Patients must be greater than 30 kg. Patients must have a platelet count greater than 100,000, a Hct greater than 27.0, a white blood count greater than 3000/microliters, and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance of greater than 60 mL/min. Patients with elevations in hepatic transaminases secondary to the presence of metastatic disease in the liver are eligible. Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent. The patient's disease in the liver must be considered unresectable as defined by greater than three sites of disease in the liver, bilobar disease, tumor abutting major vascular or ductal structures making anatomic resection with preservation of liver function impossible, or the presence of limited extrahepatic disease. EXCLUSION CRITERIA: Pregnant patients and nursing mothers will be excluded due to the unknown effects of melphalan on the fetus or newborn. Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible. Patients with active infections are not eligible. Patients with HIV disease are not eligible due to the risk of leaving a foreign body (arterial port) in the abdomen. Patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be excluded. Patients with a history of congestive heart failure with an LVEF less than 40 percent will be excluded. Patients with COPD or other chronic pulmonary disease with PFT's less than 50 percent predicted for age will be excluded. Patients with a history of VOD are ineligible.
Total Enrollment: 50
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990093; 99-C-0093
Study Start Date: April 15, 1999
Record last reviewed: March 15, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001809
Other Neoplasm Metastasis Studies:
1. Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 (SC-58635) in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients and Carriers
2. Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients with Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities
3. A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver
4. A Phase I Study of Isolated Hepatic Perfusion with Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver
5. A Phase I/II Trial of Vaccination with Mutant Ras Peptide Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients with Colorectal Cancer
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A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver
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