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Home > "U" Clinical Trials Conditions > UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors  UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Maryland Greenebaum Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with carboplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of UCN-01 and carboplatin when administered in combination in patients with advanced solid tumors. - Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the antitumor effect of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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. PROJECTED ACCRUAL: Approximately 3-30 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 metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer effective - Brain metastases allowed provided the following treatment requirements are met: - Asymptomatic or clinically stable disease after surgery or radiotherapy - No concurrent requirement for steroids or antiseizure medications - More than 2 weeks since prior therapy (e.g., surgery or CNS irradiation) for brain metastases - Recovered from prior therapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - See Radiotherapy - History of coronary artery disease allowed provided LVEF is at least 45% by MUGA or echocardiogram - No symptomatic cardiac disease Pulmonary: - History of pulmonary disease allowed provided FEV_1is at least 1 liter Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biological composition to study drugs - No prior severe allergic reaction to cisplatin or carboplatin - No insulin-dependent diabetes mellitus - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carmustine) and recovered Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - Prior radiotherapy to the mediastinum is allowed provided LVEF is at least 45% by MUGA or echocardiogram Surgery: - See Disease Characteristics Other: - No other concurrent investigational or commercial agents for malignancy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinEdelman, Study Chair, University of Maryland Greenebaum Cancer Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Additional Information:
Study ID Numbers: CDR0000069321; NCI-5533,MSGCC-0143
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036777
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Cancer
2. Irinotecan in Treating Patients With Advanced Solid Tumors
3. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
5. Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
Related Studies:
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UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
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