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Home > "U" Clinical Trials Conditions > UCN-01 and Irinotecan in Treating Patients With Metastatic or Unresectable Solid Tumors  UCN-01 and Irinotecan in Treating Patients With Metastatic or Unresectable Solid Tumors
UCN-01 and Irinotecan in Treating Patients With Metastatic or Unresectable Solid Tumors
For Condition: Cancer
Status: Recruiting
Sponsor(s): Washington University School of Medicine , 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. UCN-01 may help irinotecan kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have metastatic or unresectablesolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of UCN-01 and irinotecan in patients with resistant solid tumors. - Determine the dose-limiting toxicity of this regimen in these patients. - Determine the types of toxic effects of this regimen in these patients. - Determine any anti-tumor activity of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and UCN-01 IV over 3 hours on days 2 and 23. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan 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: A total of 18-21 patients will be accrued for this study within 6-11 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective, including the following: - Gastrointestinal tract cancer - Lung cancer - Breast cancer - Ovarian cancer - Endometrial cancer - Cervical cancer - Prostate cancer - Head and neck cancer - No known brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Not specified Menopausal status: - Not specified 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 3 times upper limit of normal (ULN) - No Gilbert's disease - No chronic unconjugated hyperbilirubinemia Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic cardiac dysfunction Pulmonary: - No symptomatic pulmonary dysfunction - Oxygen saturation at least 90% by pulse oximetry on room air at rest and after walking 6 minutes - DLCO at least 60% predicted Other: - No insulin-dependent diabetes mellitus - No other uncontrolled concurrent illness - No active or ongoing infection - No psychiatric illness or social situation that would preclude study entry - No prior allergic reactions attributed to compounds of similar chemical or biological composition to UCN-01 or irinotecan - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent granulocyte colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) during the first course of study Chemotherapy: - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior irinotecan allowed Endocrine therapy: - Not specified Radiotherapy: - More than 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - Concurrent warfarin allowed - Concurrent subcutaneous heparin allowed - No other concurrent investigational agents - No concurrent anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin) - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulaFracasso, Study Chair, Washington University School of Medicine
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paula Fracasso 314-454-8817
Additional Information:
Study ID Numbers: CDR0000069215; NCI-5582,WUSM-SCC-0102
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031681
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UCN-01 and Irinotecan in Treating Patients With Metastatic or Unresectable Solid Tumors
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