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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT01025089

This study evaluates the effects of cetuximab combined with cisplatin, doxorubicin, and cyclophosphamide in patients with advanced thymoma or thymic carcinoma. Eligible participants are adults with specific tumor types and adequate organ function, who haven't received prior treatments. The regimen includes cetuximab infusions followed by surgery if no disease progression occurs.

Patient Parameters

Program Overview

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

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010-3000DuarteCalifornia
Memorial Sloan Kettering at Basking Ridge07920Basking RidgeNew Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk11725CommackNew York
Memorial Sloan Kettering West Harrison10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center10591Sleepy HollowNew York
Md Anderson Cancer Center77030HoustonTexas

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