|
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent 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 Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer Clinical research trials and Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent 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 Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent 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 Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent 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 > "I" Clinical Trials Conditions > Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer  Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. II. Evaluate the toxicity and safety of this combination regimen in this patient population. III. Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients. IV. Determine pharmacodynamic models of irinotecan and its SN-38 and SN-38G metabolites when administered in this weekly combination schedule. PROTOCOL OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV concurrently with paclitaxel IV weekly. Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained. Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2 is reached. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed non hematologic malignancy refractory to standard therapy, or for which no known effective therapies exist --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Prior paclitaxel allowed; No prior irinotecan; At least 4 weeks since prior chemotherapy - Endocrine therapy: No concurrent steroids - Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 3 months - Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 2,000/mm3; Absolute lymphocyte count at least 1,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminase no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 1.4 mg/dL - Cardiovascular: No myocardial infarction within 6 months; No current, uncontrolled cardiac arrhythmias - Other: No history of anaphylactic reactions; Not pregnant; Fertile patients must use effective contraception; No serious uncontrolled, concurrent medical disorder
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Additional Information:
Study ID Numbers: CDR0000065386; UCCRC-8380,NCI-G97-1166
Study Start Date: November 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002939
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Methylphenidate in Treating Patients With Melanoma
2. Combination Chemotherapy in Treating Patients With Advanced Cancer
3. Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
4. SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
5. CHS 828 in Treating Patients With Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
|
|
|
|
|
|
|
|
