Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
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|ClinicalTrials.gov Identifier: NCT00021047|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 8, 2012
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/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Extrahepatic Bile Duct Cancer Gastric Cancer Head and Neck Cancer Liver Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: capecitabine Drug: carboplatin Drug: epirubicin hydrochloride||Phase 1 Phase 2|
- Determine the maximum tolerated dose and the recommended phase II dose of capecitabine administered with epirubicin and carboplatin in patients with unresectable locally advanced, metastatic, or recurrent solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics (PK) of capecitabine and correlate these PK parameters with clinical toxicity of this regimen in these patients.
- Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose and clinical toxicity of this regimen in these patients.
- Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and oral capecitabine twice daily on days 2-5, 8-12, and 15-19. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-45 patients (24 patients for phase II) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients|
|Study Start Date :||July 2001|
|Actual Study Completion Date :||June 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): NCT00021047
|United States, Maryland|
|Center for Cancer Research|
|Bethesda, Maryland, United States, 20889-5105|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Virginia|
|Naval Medical Center, Portsmouth|
|Portsmouth, Virginia, United States, 23708-2197|
|OverallOfficial:||Brian P. Monahan, MD, FACP||National Cancer Institute (NCI)|
|Study Chair:||Eva Szabo, MD||National Cancer Institute (NCI)|