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Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer Clinical research trials and Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer  Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
For Condition: adenocarcinoma of the colon,Stage 4 rectal cancer,stage 4 colon cancer,recurrent colon cancer,recurrent rectal cancer,adenocarcinoma of the rectum
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , 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. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy with gefitinib may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without gefitinib in treating patients who have metastatic or locally recurrent colorectal cancer.
Details: OBJECTIVES: - Determine the recommended phase II dose of gefitinib when administered in combination with oxaliplatin in patients with metastatic or locally recurrent colorectal cancer. - Determine the dose-limiting toxicity of this regimen in these patients. - Compare the time to progression, objective response rate, and median and overall survival in patients treated with oxaliplatin with or without gefitinib. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a phase I dose-escalation study of gefitinib followed by a phase II randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2). - Patients receive oxaliplatin IV over 2 hours on day 1 and oral gefitinib once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Patients are randomized to one of two treatment arms. - Arm I: Patients receive oxaliplatin IV over 2 hours on day 1. - Arm II: Patients receive oxaliplatin as in arm I and oral gefitinib once daily at the MTD on days 1-21. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive gefitinib alone until disease progression. PROJECTED ACCRUAL: Approximately 77 patients (9 for phase I and 68 for phase II) will be accrued for this study within 12-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection - Metastatic or locally recurrent disease - Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance - At least 1 measurable lesion - At least 20 mm by conventional techniques, including physical examination, CT scan, or MRI OR - At least 10 mm by spiral CT scan - Lesions on colonoscopic examination or barium studies, bone metastases, CNS lesions, and ascites are not considered measurable - Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given either sequentially or in combination - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No peripheral neuropathy greater than grade 1 - No other concurrent uncontrolled illness that would preclude study - No concurrent psychiatric illness or social situation that would preclude study - No ongoing or active infection - No prior allergic reaction to compounds of similar chemical or biologic composition to oxaliplatin or gefitinib - No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless considered to be at less than 30% risk of relapse after completion of therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior epidermal growth factor inhibitor - At least 24 hours since prior colony-stimulating factors - No concurrent colony-stimulating factors during first course of study therapy Chemotherapy: - See Disease Characteristics - No more than 2 prior chemotherapy regimens for metastatic disease - Prior adjuvant chemotherapy allowed - At least 4 weeks since prior cytotoxic chemotherapy and recovered - No prior cisplatin or oxaliplatin Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 4 weeks since prior surgery Other: - At least 30 days since prior investigational agents - Recovered from prior therapy - No concurrent anti-retroviral therapy for HIV - No other concurrent investigational or commercial agents or therapies for malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Loyola University Medical Center
Maywood, Illinois, 60153-5589
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000069016; NCI-3857,UCCRC-11089
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026299
Other Stage 4 Rectal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
4. Combination Chemotherapy in Treating Patients With Colon Cancer
5. Combination Chemotherapy in Treating Patients With Stage III Colon Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Michigan Clinical Trials
Other Saint Joseph Clinical Trials
Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
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