Study on Chemotherapy and Cetuximab Followed by Surgery for Advanced or Returning Thymoma or Thymic Carcinoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT01025089

This clinical trial is testing a combination of chemotherapy drugs and cetuximab to see how well they work together in treating patients with advanced or returning thymoma or thymic carcinoma before surgery. Researchers will also study changes in tumor genes to understand how they affect the treatment's effectiveness.

Patient Parameters

Program Overview

The main goal of this study is to evaluate the effects, both positive and negative, of combining cetuximab with chemotherapy drugs cisplatin, doxorubicin, and cyclophosphamide in patients with advanced thymoma or thymic carcinoma before they undergo surgery. Doctors will also examine genetic changes in the tumor to see how they might influence the effectiveness of cetuximab.

Eligibility Criteria

Inclusion Criteria

  • Must be over 18 years old.
  • Have a Karnofsky Performance Status (KPS) score of 70 or higher, indicating the ability to care for oneself.
  • Have a new or returning diagnosis of thymoma (types A, AB, B1, B2, or B3) or thymic carcinoma confirmed by specific medical centers.
  • Have not received any prior chemotherapy, radiation, or surgery for thymoma, except for a diagnostic biopsy.
  • Have not been treated with cetuximab before.
  • Have a clinical Masaoka Stage II (tumor larger than 5 cm), III, or IVA, which may include invasion into nearby areas like the chest or lungs.
  • Have normal bone marrow function, with specific blood cell counts.
  • Have adequate kidney function, with creatinine levels within a certain range.
  • Have adequate liver function, with specific levels of bilirubin and liver enzymes.
  • Be willing to sign an informed consent form.
  • Agree to use effective contraception.
  • Be medically fit for surgery.

Exclusion Criteria

  • Have evidence of cancer spread to distant parts of the body (Masaoka stage IVB).
  • Have thymic carcinoid.
  • Be receiving any other experimental treatments.
  • Have had another cancer in the past 5 years, except for certain skin or cervical cancers.
  • Be HIV-positive and on anti-retroviral therapy, due to potential interactions with study drugs.
  • Be pregnant or breastfeeding.

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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