Back to resultsEpirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring 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, 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, recurrent salivary gland cancer, stage IV salivary gland cancer
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
Sites / Locations
- Center for Cancer Research
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Naval Medical Center, Portsmouth
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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