Clinical trial · Interventional
Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
NCT00010257CI-TRIAL-00067666completedPhase 2Results postedClinicalTrials.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 chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel plus Carboplatin
- description
- Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Best Overall Response by RECIST Criteria (Version 1.0)
- timeFrame
- Assessed every 2 cycles (6 weeks)
- description
- Number of eligible, treated participants in each response category by RECIST criteria
Secondary outcomes (1)
- measure
- Duration of Response
- timeFrame
- assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery * Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy) * Advanced limited disease allowed if ineligible for primary radiotherapy or surgery * Measurable disease * Age 18 and over * ECOG Performance Status 0-1 * Granulocyte count at least 1,500 cells/mm\^3 * Platelet count at least 100,000 cells/mm\^3 * Bilirubin no greater than 1.5 mg/dL * Creatinine no greater than 2.0 mg/dL * Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed Exclusion Criteria: * Acute concurrent complications such as infection or post-surgical complications * Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence * Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception * Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year
References
Publications (2)
- BACKGROUNDLoehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004.
- RESULTLemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. doi: 10.1200/JCO.2010.32.9607. Epub 2011 Apr 18. PMID 21502559