Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Esophageal Cancer; Extrahepatic Bile Duct Cancer; Gastric Cancer; Head and Neck Cancer; Liver Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: capecitabine (Drug); carboplatin (Drug); epirubicin hydrochloride (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Institutes of Health Clinical Center (CC) Official(s) and/or principal investigator(s): Brian P. Monahan, MD, FACP, Affiliation: National Cancer Institute (NCI) Eva Szabo, MD, Study Chair, Affiliation: National Cancer Institute (NCI)
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.
Clinical Details
Official title: A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
Study design: Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Center for Cancer Research, Bethesda, Maryland 20889-5105, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia 23708-2197, United States
Additional Information
Starting date: July 2001
Last updated: March 7, 2012
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