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Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Clinical research trials and Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer. Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer  Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
For Condition: stage 4 colon cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,recurrent rectal cancer,Stage 4 rectal cancer,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): University of Pennsylvania Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with fluorouracil, leucovorin, and irinotecan may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with fluorouracil, leucovorin, and irinotecan in treating patients who have advanced or recurrentcolorectal cancer.
Details: OBJECTIVES: - Determine the safety of gefitinib, fluorouracil, leucovorin calcium, and irinotecan in patients with advanced or recurrent colorectal cancer. - Determine the major side effects of this regimen in these patients. - Determine the response rate, progression-free survival, and overall survival of patients treated with this regimen. - Correlate response and other measures of outcome with epidermal growth factor receptor expression and the expression of genes that impact upon pathways of fluoropyrimidine cytotoxicity in patients treated with this regimen. OUTLINE: This is a non-randomized, open-label, multi-center study. Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced (stage IV) or recurrent adenocarcinoma of the colon or rectum - Must have available tissue for immunohistochemical analysis - At least one unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Tumor marker (carcinoembryonic antigen) elevation alone is insufficient for study entry - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST less than 2 times ULN (5 times ULN if liver involvement of tumor) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No other severe or uncontrolled concurrent illness that would adversely impact the safety or efficacy of study therapy - No ongoing or active infection - No other prior malignancy unless curatively treated and no evidence of recurrence - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for advanced disease - More than 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - At least 6 months since prior adjuvant therapy - No prior epidermal growth factor receptor inhibitor - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent phenytoin, carbamazepine, barbiturates, rifampin, rifapentine, oxacarbazepine, modafinil, griseofulvin, or Hypericum perforatum
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterO'Dwyer, Study Chair, University of Pennsylvania Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000258548; NCI-5894,UPCC-06202
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052585
Other Stage 4 Rectal Cancer Studies:
1. Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
2. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
3. ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
4. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
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Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
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