Epirubicin, Carboplatin, and Capecitabine in Treating Pat... | NCT00021047 | Trialant
NCT00021047
Sponsor
National Institutes of Health Clinical Center (CC)
Status
Completed
Last Update Posted
Mar 8, 2012Estimated
Enrollment
Not provided
Phase
Phase 1Phase 2
Conditions
Esophageal Cancer
Extrahepatic Bile Duct Cancer
Gastric Cancer
Head and Neck Cancer
Liver Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
capecitabine
carboplatin
epirubicin hydrochloride
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00021047
Obsolete or Duplicate NCT IDs
NCT00015743
Organization Study
010172
Secondary IDs
ID
Type
Description
Link
NCI-01-C-0172
MB-NAVY-00-07
MB-NAVY-B01-008
CDR0000068741
Brief Title
Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
Official Title
A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
Acronym
Not provided
Organization
National Institutes of Health Clinical Center (CC)NIH
Status Module
Record Verification Date
Mar 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2001
Primary Completion Date
Not provided
Completion Date
Jun 2004Actual
First Submitted Date
Jul 11, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 7, 2012
Last Update Posted Date
Mar 8, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Institutes of Health Clinical Center (CC)NIH
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
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.
Detailed Description
OBJECTIVES:
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.
Conditions Module
Conditions
Esophageal Cancer
Extrahepatic Bile Duct Cancer
Gastric Cancer
Head and Neck Cancer
Liver Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
capecitabine
Drug
carboplatin
Drug
epirubicin hydrochloride
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
Progressive disease on standard therapy, including:
Locally advanced, unresectable primary or recurrent tumor OR
Metastatic disease
Previously untreated metastatic cancer for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancers for which no effective standard therapy exists) allowed
Phase II portion:
Diagnosis of cancer of the upper aerodigestive tract (head and neck, esophagus, stomach, or hepatobiliary)
No potential curative treatment options including surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy
No leukemia or lymphoma
No primary CNS malignancies or CNS metastases
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute granulocyte count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
AST and ALT no greater than 2.5 times upper limit of normal
Renal:
Creatinine no greater than 1.6 mg/dL
Cardiovascular:
LVEF at least 50%
No symptomatic congestive heart failure
No unstable angina
No cardiac arrhythmia
Other:
No serious concurrent medical illness that would preclude study participation
No active infections requiring IV antibiotic therapy
No history of allergy to platinum compounds, mannitol, or antiemetics used with study drugs
No history of severe intolerance to fluorouracil
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
More than 4 weeks since prior immunotherapy and recovered
Chemotherapy:
See Disease Characteristics
More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
No prior cumulative doxorubicin dose of more than 300 mg/m2
Endocrine therapy:
Not specified
Radiotherapy:
See Disease Characteristics
At least 2 weeks since prior radiotherapy and recovered
At least 8 weeks since prior strontium chloride Sr 89
Surgery:
See Disease Characteristics
Recovered from prior surgery
Other:
At least 4 weeks since prior sorivudine or brivudine
No concurrent sorivudine or brivudine
No concurrent cimetidine
No concurrent antiretroviral therapy for HIV-positive patients
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Brian P. Monahan, MD, FACP
National Cancer Institute (NCI)
Eva Szabo, MD
National Cancer Institute (NCI)
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Center for Cancer Research
Bethesda
Maryland
20889-5105
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
recurrent lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity