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AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors Clinical research trials and AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors clinical trial. Participants frequently obtain the most expert healthcare available for their AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors  AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): UAB Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FranciscoRobert, Study Chair, UAB Comprehensive Cancer Center
Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068699; UAB-0052,UAB-F001227008,NCI-G01-1954,AG-2037-003-A2
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017524
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. E7070 in Treating Patients With Solid Tumors
2. Gemcitabine and Flavopiridol in Treating Patients With Solid Tumors
3. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. 3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
5. Oxaliplatin and Gemcitabine in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
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