Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35294


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor. - Determine the safety and tolerance of this drug in these patients. - Assess the pharmacokinetics of this drug in these patients. - Document any antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor - Advanced, metastatic, or recurrent disease - No curative therapy exists - Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome) - SGOT OR SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min Other: - No unstable or severe concurrent medical condition that would preclude study participation - No sociological or familial condition that would preclude study compliance - No psychological or addictive disorder that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 40% of bone marrow Surgery: - Not specified Other: - At least 2 weeks since prior blood transfusions - At least 4 weeks since prior investigational agent and recovered - No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitor - No concurrent extradietary folate supplements - No concurrent allopurinol - No other concurrent anticancer or investigational agents


NCT ID:

NCT00017524


Primary Contact:

Study Chair
Francisco Robert, MD, FACP
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.