Expired Study
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Buffalo, New York 14263


Purpose:

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 combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors. - Determine the antitumor activity and toxicity of this regimen in these patients. - Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. - Determine the optimal dose and time interval for this regimen in these patients. OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment - Considered incurable with other modalities - Measurable or evaluable disease - The following are not considered measurable or evaluable: - Bone metastases - Pleural, pericardial, or peritoneal effusions - Irradiated lesions (unless progression is documented after radiotherapy) - Metastatic disease that has been followed using serum tumor markers allowed - No symptomatic brain metastases - Brain metastases may not be sole site of metastatic disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 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 - AST and ALT no greater than 1.5 times normal - Bilirubin no greater than 1.5 mg/dL - No clinically apparent jaundice Renal - Creatinine no greater than 1.6 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular - Cardiac function normal - No uncontrolled heart disease - No myocardial infarction within the past 3 months - No congestive heart failure - No unstable or uncontrolled angina Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No active infection requiring systemic therapy - No uncontrolled seizures - No uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior gemcitabine - No prior camptothecin compounds - Prior irinotecan allowed - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 14 days since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 30 days since prior clinical trial participation - No other concurrent investigational medications


NCT ID:

NCT00054288


Primary Contact:

Study Chair
Nithya Ramnath, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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