Clinical trial · Interventional
Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patientsReferences
Publications (0)
Data not yet available