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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thymoma, Thymic Carcinoma., Clinical Masaoka Stage II-IVA

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Trial Information

A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma


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 or MDACC

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

James Huang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

09-038

NCT ID:

NCT01025089

Start Date:

December 2009

Completion Date:

December 2014

Related Keywords:

  • Thymoma
  • Thymic Carcinoma.
  • Clinical Masaoka Stage II-IVA
  • Cetuximab
  • Cisplatin
  • Cyclophosphamide
  • 09-038
  • Carcinoma
  • Thymoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York