|
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer Clinical research trials and ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer. ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "Z" Clinical Trials Conditions > ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer  ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ZD 1839 with combination chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic colorectal cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of ZD 1839 in combination with irinotecan, leucovorin calcium, and fluorouracil in patients with locally advanced, locally recurrent, or metastatic colorectal cancer. II. Determine the dose-limiting toxicity of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the objective response rate in patients treated with this regimen. V. Correlate epidermal growth factor receptor expression with the probability of objective tumor response in these patients. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study of ZD 1839. Patients receive oral ZD 1839 daily. Beginning on day 15, patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15 minutes, and fluorouracil IV weekly on weeks 1-2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ZD 1839 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. Once the MTD is determined, 10 additional patients are accrued to receive treatment at the MTD. Patients are followed for 30 days. PROJECTED ACCRUAL: Approximately 3-22 patients will be accrued for this study within 1-6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum - Locally advanced, locally recurrent, or metastatic disease - Not curable by surgery and/or not amenable to radiotherapy with curative intent - Histological or cytological confirmation of metastatic cancer not required for patients with prior surgically resected colorectal cancer if more than 5 years elapsed between primary surgery and development of metastatic disease OR if primary cancer was stage I or II Prior adjuvant therapy with fluorouracil or immunotherapy for resected stage II, III, or IV disease allowed Measurable disease No known brain metastases --Prior/Concurrent Therapy-- Biologic therapy: - See Disease Characteristics - At least 12 months since prior immunotherapy Chemotherapy: - See Disease Characteristics - At least 12 months since prior fluorouracil - No prior chemotherapy for advanced colorectal cancer - No prior irinotecan Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to more than 15% of bone marrow - At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy) - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery (e.g., laparotomy) and recovered - At least 2 weeks since prior minor surgery and recovered - No concurrent ophthalmic surgery Other: - No prior ZD 1839 - No other concurrent investigational or commercial agents or therapies for malignancy - No concurrent combination antiretroviral therapy for HIV - No concurrent oral retinoids - No concurrent prochlorperazine on day of irinotecan administration --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 12 weeks Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin normal - AST/ALT no greater than 5 times upper limit of normal Renal: Creatinine normal Cardiovascular: - No uncontrolled high blood pressure - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction within the past 6 months - No serious uncontrolled cardiac arrhythmia - No New York Heart Association class III or IV heart disease Other: - No active or uncontrolled infection - No predisposing colonic or small bowel disorders with uncontrolled symptoms as indicated by more than 3 loose stools daily in patients without a colostomy or ileostomy - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas - No other concurrent medical or psychiatric condition that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesFuchs, Study Chair, Dana-Farber/Harvard Cancer Center
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000069023; NCI-3792,DFCI-NCI-3792
Study Start Date: November 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026364
Other Recurrent Rectal Cancer Studies:
1. Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
4. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
Related Studies:
Other recurrent rectal cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
|
|
|
|
|
|
|
|
