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NCT Number: NCT01025089

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thymoma Clinical Masaoka Stage II to IVA Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Thymic Carcinoma Thymus Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope Medical Center, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide

Drug

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.

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab

    Time frame: 2 years

  2. To measure the radiographic response rate to cetuximab alone after 4 weeks

    Time frame: 4 weeks

  3. To determine the radiographic response rate to CAP and cetuximab

    Time frame: 2 years

  4. To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab

    Time frame: 2 years

  5. To correlate percentage of pathologic response to unidimensional and volumetric radiographic response

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • City of Hope National Medical Center
  • Eli Lilly and Company
  • M.D. Anderson Cancer Center

Registry information

Official study title

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)

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2009
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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