|
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021047 |
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 | Intervention | 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 I Phase II |
MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Liver Cancer Stomach Cancer |
ChemIDplus related topics: | Carboplatin Capecitabine Epirubicin hydrochloride Epirubicin Salicylsalicylic acid Sodium salicylate |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients |
Study Start Date: | July 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
Progressive disease on standard therapy, including:
Phase II portion:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Investigator: | Brian P. Monahan, MD, FACP | National Cancer Institute (NCI) |
Study Chair: | Eva Szabo, MD | National Cancer Institute (NCI) |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000068741, NCI-01-C-0172, MB-NAVY-00-07, MB-NAVY-B01-008 |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00021047 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|