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E7389 in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on E7389 in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. E7389 in Treating Patients With Advanced Solid Tumors Clinical research trials and E7389 in Treating Patients With Advanced Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like E7389 in Treating Patients With Advanced Solid Tumors. E7389 in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a E7389 in Treating Patients With Advanced Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their E7389 in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > E7389 in Treating Patients With Advanced Solid Tumors  E7389 in Treating Patients With Advanced Solid Tumors
E7389 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): California Cancer Consortium , 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. PURPOSE: Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of E7389 in patients with advanced solid tumors. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the in vivo anti-mitotic activity of this drug before and after treatment in these patients. - Determine, preliminarily, the target validation feasibility of this drug in patients with biopsy-accessible tumor. - Determine the clinical response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Additional patients with biopsy-accessible tumors are accrued and treated as above at the MTD. PROJECTED ACCRUAL: Approximately 31 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 solid tumor refractory to standard therapy or for which no standard therapy exists - Tumors must be accessible for repeated biopsy in patients in the expanded cohort (at the maximum tolerated dose) - Evaluable disease - Pleural effusions, ascites, and bone metastases are evaluable - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 2 months Hematopoietic - 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 - SGOT and SGPT 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 poorly controlled cardiovascular disease - No severe cardiovascular disease that would preclude study Pulmonary - No poorly controlled pulmonary disease - No severe pulmonary disease that would preclude study Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No poorly controlled CNS disease - No severe CNS disease that would preclude study - No other poorly controlled nonmalignant disease - No other severe nonmalignant disease that would preclude study - No active severe infection requiring therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 8 weeks for UCN-01) and recovered Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Recovered from prior major surgery Other - No concurrent antiretroviral medications for HIV-positive patients - No other concurrent investigational drugs - No other concurrent antineoplastic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMorgan, Study Chair, Beckman Research Institute
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Robert Morgan 626-359-8111
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Gandara 916-734-3772
City of Hope Medical Group *Recruiting*
Pasadena, California, 91105
United States
Recruiting Mark McNamara 626-396-2900
Additional Information:
Study ID Numbers: CDR0000257235; NCI-5730,CCC-PHI-39,CHNMC-PHI-39
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047034
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
2. VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Prior Therapy
3. VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
4. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
5. Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
E7389 in Treating Patients With Advanced Solid Tumors
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