Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:December 2009
End Date:December 2019

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A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma (BMS #CA225-331/Lilly Trial Alias I4E-US-X007)

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


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
We found this trial at
8
sites
1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Basking Ridge, New Jersey 07920
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Commack, NY
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Duarte, California 91010
Principal Investigator: Dan Raz, MD
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Duarte, CA
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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Houston, Texas 77030
Principal Investigator: George Simon, MD
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Houston, TX
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: James Huang, MD
Phone: 646-888-3055
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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701 N Broadway
Sleepy Hollow, New York 10591
(914) 366-3000
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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mi
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Sleepy Hollow, NY
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