Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
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ClinicalTrials.gov Identifier: NCT01025089 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 3, 2009
Last Update Posted
: April 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Thymoma Thymic Carcinoma Clinical Masaoka Stage II to IVA | Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Study Start Date : | December 2009 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
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Experimental: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
This is a multicenter, open-label phase II trial of neoadjuvant chemotherapy and concurrent cetuximab in patients with clinical Masaoka stage II-IVA thymoma or thymic carcinoma.. Patients will initially receive weekly cetuximab for 4 weeks to assess tumor response to cetuximab alone. Patients will then undergo weekly cetuximab along with concurrent CAP for 4 cycles. At the completion of this regimen, patients will undergo surgical resection and the specimen will be evaluated for CPR.
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Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
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.
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- 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 ]
- To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab [ Time Frame: 2 years ]
- To measure the radiographic response rate to cetuximab alone after 4 weeks [ Time Frame: 4 weeks ]
- To determine the radiographic response rate to CAP and cetuximab [ Time Frame: 2 years ]
- To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab [ Time Frame: 2 years ]
- To correlate percentage of pathologic response to unidimensional and volumetric radiographic response [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025089
United States, California | |
City of Hope Medical Center | |
Duarte, California, United States, 91010-3000 | |
United States, New Jersey | |
Memorial Sloan Kettering at Basking Ridge | |
Basking Ridge, New Jersey, United States, 07920 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center @ Suffolk | |
Commack, New York, United States, 11725 | |
Memorial Sloan Kettering West Harrison | |
Harrison, New York, United States, 10604 | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Memorial Sloan Kettering at Mercy Medical Center | |
Rockville Centre, New York, United States | |
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center | |
Sleepy Hollow, New York, United States, 10591 | |
United States, Texas | |
Md Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | James Huang, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01025089 History of Changes |
Other Study ID Numbers: |
09-038 |
First Posted: | December 3, 2009 Key Record Dates |
Last Update Posted: | April 6, 2018 |
Last Verified: | April 2018 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
Cetuximab Cisplatin Cyclophosphamide 09-038 |
Additional relevant MeSH terms:
Carcinoma Thymoma Thymus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Thoracic Neoplasms Neoplasms by Site Lymphatic Diseases Liposomal doxorubicin Cisplatin Cyclophosphamide Doxorubicin |
Cetuximab Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |