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| Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017524 |
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.
| Condition | Intervention | Phase |
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: AG2037 |
Phase I |
| MedlinePlus related topics: | Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 | |||||
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
| National Cancer Institute (NCI) |
| Study Chair: | Francisco Robert, MD, FACP | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068699, UAB-0052, AG-2037-003-A2, UAB-F001227008, NCI-G01-1954 |
| First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017524 |
| Health Authority: | United States: Federal Government |
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