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UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors Clinical research trials and UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors. UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors clinical trial. Human subjects often get the best healthcare available for their UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors  UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
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 UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors. II. Assess the toxicity and potential antitumor activity of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study of cisplatin. Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of cisplatin 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. Patients are followed every 2-3 months for at least 1 year. PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed advanced or metastatic solid tumor incurable by surgery or other standard therapy Tumor site accessible by biopsy No brain metastasis --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No greater than 2 prior chemotherapy regimens - Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2 Endocrine therapy: Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - See Disease Characteristics - Recovered from any prior surgery Other: - At least 30 days since prior investigational drugs - No other concurrent investigational drugs - No other concurrent anticancer agents --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: - WBC at least 4,500/mm3 - Absolute neutrophil count at least 2,000/mm3 - Platelet count at least 150,000/mm3 Hepatic: - Bilirubin normal - SGOT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal - Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV congestive heart failure Other: - No peripheral neuropathy greater than grade I - No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study - No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration - No medical, social, or psychological factors that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidGandara, Study Chair, Beckman Research Institute
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
City of Hope Medical Group
Pasadena, California, 91105
United States
Additional Information:
Study ID Numbers: CDR0000068274; NCI-T99-0065,CHNMC-PHI-28
Study Start Date: March 2001
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006464
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
2. Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
3. LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
4. Improving Pain Management in Patients With Nonhematologic Cancer
5. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
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UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
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