AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
|ClinicalTrials.gov Identifier: NCT00017524|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: pelitrexol||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer|
|Study Start Date :||March 2001|
|Actual Study Completion Date :||November 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017524
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Francisco Robert, MD, FACP||University of Alabama at Birmingham|