Clinical Masaoka Stage II to IVA, Thymic Carcinoma, Thymoma
Conditions
Keywords
Cetuximab, Cisplatin, Cyclophosphamide, 09-038
Brief summary
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
Interventions
DRUGCetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Patients will receive single agent cetuximab infusion starting with a 400mg/m2 IV loading dose on day 1 of week 1, followed by weekly infusions (250mg/m2) on day 1 of weeks 2 3, and 4. Patients will receive single agent cetuximab infusion starting with a 400mg/m2 IV loading dose on day 1 of week 1, followed by weekly infusions (250mg/m2) on day 1 of weeks 2 3, and 4. Patients who have completed the neo-adjuvant treatment regimen, who have no evidence of distant progression, and who are medically operable will proceed to surgical resection within 6 weeks of the last infusion.
Sponsors
Memorial Sloan Kettering Cancer Center
Eli Lilly and Company
M.D. Anderson Cancer Center
City of Hope National Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the frequency of complete pathologic response to neo-adjuvant therapy with cisplatin, doxorubicin, cyclophosphamide (CAP) and cetuximab in patients with clinical Masaoka stage II-IVa thymoma and thymic carcinomas. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab | 2 years |
| To measure the radiographic response rate to cetuximab alone after 4 weeks | 4 weeks |
| To determine the radiographic response rate to CAP and cetuximab | 2 years |
| To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab | 2 years |
| To correlate percentage of pathologic response to unidimensional and volumetric radiographic response | 2 years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Huang, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed