Expired Study
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Baltimore, Maryland 21231


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 chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors, primarily lung, ovarian, and gastrointestinal tumors. - Determine the acute and chronic toxicity profile of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the anti-tumor effect of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan 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. At least 6 patients are treated at the recommended phase II dose. Patients are followed at 1 month. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 7-15 months.


DISEASE CHARACTERISTICS: - Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative therapy does not exist or is no longer effective - Gastrointestinal, lung, and ovarian malignancies are given priority - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months 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 (ULN) Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic coronary artery disease - No symptomatic cardiac dysfunction - No symptoms suggestive of coronary artery disease - LVEF at least 50% Pulmonary - No symptomatic pulmonary dysfunction - FEV_1 greater than 75% of predicted - DLCO greater than 75% of predicted Other - Amylase no greater than 2 times ULN - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No diabetes mellitus or random glucose more than 200 mg/dL - No prior allergic reaction attributed to compounds of similar biological or chemical composition to UCN-01 or irinotecan (including rash and systemic allergic reaction causing hypotension and respiratory distress) - No chronic diarrhea (more than 5 stools/day) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 14 days before, during, and for at least 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior UCN-01 and irinotecan allowed Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - No prior mediastinal radiation Surgery - Not specified Other - At least 14 days since prior warfarin - No concurrent warfarin unless required for maintaining patency of existing, permanent IV catheters - No concurrent commercial or other investigational anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients



Primary Contact:

Study Chair
Ross C. Donehower, MD
Sidney Kimmel Comprehensive Cancer Center

Backup Contact:


Location Contact:

Baltimore, Maryland 21231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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