|
Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer Clinical research trials and Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer  Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
For Condition: Stage 4 rectal cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,stage 4 colon cancer,liver metastases
Status: Not yet recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus cetuximab in treating patients who have unresectablelivermetastases from colorectal cancer.
Details: OBJECTIVES: - Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma expressing epidermal growth factor receptor (EGFR) treated with oxaliplatin, fluorouracil, leucovorin calcium, and cetuximab. - Determine the response rate and overall survival of patients treated with this regimen. - Determine, preliminarily, the importance of EGFR levels in predicting response in patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1 hour (except over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 20 minutes on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - History of completely resected primary adenocarcinoma of the colon or rectum - No gross or microscopic evidence of residual disease - Liver metastases, meeting 1 of the following criteria: - Not optimally resectable - Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or the retrohepatic vena cava - Includes the main right or main left portal vein and the main hepatic vein of the opposite lobe - Requires more than a right or left trisegmentectomy - At least 6 metastatic lesions distributed diffusely in both lobes of the liver - Tumor expressing epidermal growth factor receptor (EGFR) - No evidence of extrahepatic metastases by physical examination or x-ray - No previously resected extrahepatic metastases - At least 1 measurable lesion at least 20 mm PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin at least 9 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST no greater than 3 times upper limit of normal (ULN) - Bilirubin no greater than ULN - No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that would preclude surgical resection of metastases Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No myocardial infarction within the past 6 months - No clinical evidence of congestive heart failure - No significant cardiac disease - No uncontrolled hypertension - No unstable angina - No congestive heart failure - No uncontrolled arrhythmias Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Adequate oral nutrition with estimated caloric intake of at least 1,500 calories/day - Able to tolerate major surgery - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ, or tumors associated with less than 10% probability of death within 5 years of diagnosis - No severe anorexia or frequent nausea and/or vomiting - No grade 2 or greater preexisting neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - No colony-stimulating factors within 24 hours of day 1 of each course - No concurrent immunotherapy Chemotherapy - At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole or with or without leucovorin calcium - No prior systemic chemotherapy for metastatic disease - No prior chemoembolization for metastatic disease - No prior hepatic artery infusion chemotherapy for metastatic disease - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the liver - No prior radiotherapy to more than 25% of the bone marrow - At least 12 months since prior adjuvant radiotherapy - Prior radiofrequency ablation allowed - No concurrent radiotherapy Surgery - See Disease Characteristics - More than 21 days since prior abdominal exploration (with or without intestinal resection) Other - No prior anti-EGFR-directed therapy - Prior cryotherapy allowed - No oral cryotherapy on day 1 of each course
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, Mayo Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000271923; NCCTG-N014A
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056030
Other Adenocarcinoma Of The Rectum Studies:
1. Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
2. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
3. Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
4. ZD 1839 in Treating Patients With Recurrent Metastatic Colorectal Cancer
5. Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver
Related Studies:
Other adenocarcinoma of the rectum Clinical Trials
Other Clinical Trials
Other Clinical Trials
Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
|
|
|
|
|
|
|
|
