Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
Running, not enrolling · Phase 2
Conditions studied: Thymoma, Thymic Carcinoma, Clinical Masaoka Stage II to IVA
In brief
The main purpose of this study is to find out the good and the bad effects that the combination of cetuximab with the traditional chemotherapy regimen of cisplatin, doxorubicin, and cyclophosphamide has when given to patients with later stage thymoma or thymic carcinoma before surgery. The physicians will also look at changes in genes in the tumor that may relate to the effectiveness of cetuximab
Key facts
- Study ID
- NCT01025089
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 18
- Starts
- 2009-12-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age>18
- Karnofsky Performance Status (KPS) ≥ 70
- Newly diagnosed or recurrent thymoma - WHO A, AB, B1, B2, or B340, or thymic carcinoma pathologically confirmed at MSKCC, MDACC or City of Hope
- No prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma
- No prior treatment with cetuximab
- Clinical Masaoka Stage II (>5cm), III, or IVA(See Appendix B), including suspected invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or pleural metastases Normal marrow function: leukocytes ≥ 4,000/μl, absolute neutrophil count ≥ 1,500/μl, platelets ≥ 160,000/μl
- Adequate renal function, with creatinine ≤ 1.3 mg/dl or calculated creatinine clearance ≥60ml/min by Cockcroft and Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
- Adequate hepatic function: Total bilirubin ≤1.5 mg/dl, AST ≤1.5X UNL, alkaline phosphatase ≤1.5 UN
- Signed informed consent
- Effective contraception
- Medically operable
You may not qualify if…
- Evidence of distant metastatic disease (Masaoka stage IVB)
- Thymic carcinoid
- Patients must not be receiving any other investigational agents
- Concurrent or prior malignancy in the last 5 years other than non-melanoma skin cancer and in-situ carcinoma of the cervix
- Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs. Patients on medications known to alter CYP3A4
- Pregnant or breastfeeding women
Where it is running
- City of Hope Medical Center — Duarte, California, United States
- Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
- Memorial Sloan Kettering West Harrison — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States
- Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center — Sleepy Hollow, New York, United States
- Md Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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