Clinical trial · Interventional
Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma
Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma
NCT00017186CI-TRIAL-00025053completedPhase 2ClinicalTrials.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 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 II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine + epirubicin
- description
- Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR. Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
- interventionNames
- Drug: epirubicin hydrochloride
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- time to progression
- timeFrame
- Up to 5 years
Secondary outcomes (2)
- measure
- survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant pleural mesothelioma * At least 1 measurable lesion that can be accurately measured in at least one dimension * At least 20 mm (2 cm) in diameter PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * LVEF at least 50% * No history of congestive heart failure * No New York Heart Association class III or IV heart disease Other: * No uncontrolled infection * No other severe underlying disease that would preclude study participation * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Chemotherapy: * No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma * No prior gemcitabine or anthracyclines Other: * No concurrent cimetidine
References
Publications (2)
- BACKGROUNDHuschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444. PMID 17211864
- RESULTOkuno SH, Delaune R, Sloan JA, Foster NR, Maurer MJ, Aubry MC, Rowland KM Jr, Soori GS, Nikcevich DA, Kardinal CG, Northfelt DW, Adjei AA; North Central Cancer Treatment Group. A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma: a North Central Cancer Treatment Study, N0021. Cancer. 2008 Apr 15;112(8):1772-9. doi: 10.1002/cncr.23313. PMID 18224661