AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|