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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00021047 |
Purpose
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 |
| 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.
Eligibility| 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:
Contacts and Locations| 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) |
More Information
| Study ID Numbers: | CDR0000068741, NCI-01-C-0172, MB-NAVY-00-07, MB-NAVY-B01-008 |
| Study First Received: | July 11, 2001 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00021047 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV gastric cancer recurrent gastric cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer recurrent esophageal cancer advanced adult primary liver cancer recurrent adult primary liver cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer unspecified adult solid tumor, protocol specific untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip |
stage IV verrucous carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip recurrent verrucous carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx recurrent lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx |
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Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Antibiotics, Antineoplastic Liver Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Biliary Tract Diseases Therapeutic Uses |
Capecitabine Digestive System Neoplasms Biliary Tract Neoplasms Carboplatin Epirubicin Pharmacologic Actions Neoplasms Digestive System Diseases Bile Duct Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Bile Duct Neoplasms Esophageal Diseases |