Combination Chemotherapy in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00024323|
Recruitment Status : Completed
First Posted : June 20, 2003
Last Update Posted : July 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: triapine||Phase 1|
- Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the antitumor responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin|
|Study Start Date :||March 2001|
|Actual Study Completion Date :||June 2003|
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): NCT00024323
|United States, Arizona|
|Arizona Clinical Research Center|
|Tucson, Arizona, United States, 85712|
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|