Clinical trial · Interventional
Capecitabine, Epirubicin, and Carboplatin in Treating Patients With Progressive, Unresectable, or Metastatic Cancer
A Phase I Trial of Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients
NCT00486356CI-TRIAL-00072706completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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, such as capecitabine, epirubicin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with epirubicin and carboplatin in treating patients with progressive, unresectable, or metastatic cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| microarray analysis | Genetic | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine, Epirubicin, and Carboplatin
- description
- Determine the recommended phase II dose of capecitabine when given together with epirubicin and carboplatin in treating patients with progressive, unresectable, or metastatic cancer.
- interventionNames
- Drug: capecitabine
- Drug: carboplatin
- Drug: epirubicin hydrochloride
- Genetic: microarray analysis
- Genetic: polymorphism analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Recommended phase II dose of capecitabine
- timeFrame
- Every 28-days until first documented progression up to 63 months
- description
- Establish a recommended Phase II dose of oral capecitabine given twice daily on days 2-5, 8-12, and 15-19 in combination with fixed IV doses of epirubicin and carboplatin given day 1 of each 28-day cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed cancer, meeting 1 of the following criteria: * Disease that has progressed on standard therapy * Locally advanced but unresectable primary or recurrent solid tumor * Metastatic disease, including previously untreated metastatic disease for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancer for which no effective standard therapy exists) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) ≤ 2.5 times ULN * Creatinine ≤ 1.6 mg/dL * Left ventricular ejection fraction ≥ 50% * Fertile patients must use effective contraception * Recovered from prior therapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) or immunotherapy * At least 2 weeks since prior radiotherapy * At least 8 weeks since prior strontium therapy * At least 4 weeks since prior and no concurrent sorivudine or brivudine Exclusion Criteria: * No other potentially curative treatment options available (e.g., surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy) * No leukemia or lymphoma * No primary central nervous system (CNS) malignancies or CNS metastases * No other medical illness that would preclude study treatment * No active infection requiring IV antibiotic therapy unless the infection has resolved * No history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy * No history of unexpectedly severe intolerance to fluorouracil * Not pregnant or nursing/negative pregnancy test * No prior doxorubicin at cumulative doses \> 300 mg/m² * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent cimetidine
References
Publications (0)
Data not yet available
No reference posted for this study.