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SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer Clinical research trials and SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer  SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
For Condition: recurrent rectal cancer,stage 3 rectal cancer,adenocarcinoma of the rectum,Stage 4 rectal cancer,stage 3 colon cancer,recurrent colon cancer,stage 4 colon cancer,adenocarcinoma of the colon
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of SU5416 in combination with irinotecan in patients with advanced colorectal cancer. II. Determine time to disease progression, objective response rate, and survival time in these patients receiving this regimen at the MTD. III. Evaluate the safety and tolerance of this regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation study of SU5416. Patients receive irinotecan IV over 90 minutes on day 1 of weeks 1-4 and SU5416 IV over 60 minutes on days 1 and 4 of weeks 1-6. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of SU5416 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, additional patients are accrued to receive treatment with SU5416 and irinotecan at the recommended phase II dose. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 12 months. An additional 44 patients will be accrued for the phase II portion of this study within 7 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed locally advanced or metastatic adenocarcinoma of the colon or rectum not amenable to potentially curative treatment - Measurable or evaluable disease - Measurable disease defined as at least 1 bidimensionally measurable lesion at least 1 x 1 cm that is outside field of any prior radiotherapy - Must have received a prior chemotherapy regimen containing a fluorinated pyrimidine - No more than 2 prior chemotherapy regimens for locally advanced or metastatic disease in phase I and only 1 prior chemotherapy regimen for locally advanced or metastatic disease in phase II - If progression while on or within 6 months of adjuvant therapy, the adjuvant regimen is considered treatment for metastatic disease - No history of or clinically apparent CNS metastases or leptomeningeal carcinomatosis disease --Prior/Concurrent Therapy-- - Biologic therapy: No prophylactic hematopoietic growth factors (e.g., filgrastim (G-CSF)); No concurrent biologic therapy - Chemotherapy: See Disease Characteristics; No prior SU5416, irinotecan, or any topoisomerase I inhibitor; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: At least 4 weeks since prior major surgery and recovered - Other: At least 30 days since other prior investigational drugs; No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis; No concurrent prochlorperazine on day of irinotecan administration; No other concurrent anticancer therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 3 times upper limit of normal; No known Gilbert's disease - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination; No history of myocardial infarction; No severe/unstable angina in the past 6 months; No deep venous or arterial thrombosis within past 3 months - Pulmonary: No pulmonary embolism within past 3 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; History of prior malignancy allowed (phase I only); No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer (phase II); No uncontrolled diabetes mellitus; No known allergy to Cremophor or Cremophor-based drug products; No active or uncontrolled infection; No psychiatric disorders that would preclude study; No history of seizures; No other severe concurrent disease that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesAbbruzzese, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067823; MDA-ID-99243,NCI-88
Study Start Date: June 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005818
Other Stage 4 Colon Cancer Studies:
1. Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
4. Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer
5. Gene Testing in Patients With Colon Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
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