Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced⦠(NCT00021047) | Clinical Trial Compass
CompletedPhase 1/2
Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
United StatesStarted 2001-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, ā¦
Trial details
NCT IDNCT00021047
SponsorNational Institutes of Health Clinical Center (CC)