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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Thymoma; Thymic Carcinoma; Clinical Masaoka Stage II to IVA	Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide	Phase 2

Study Design

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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

Arms and Interventions

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Arm

Intervention/treatment

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.

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.

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Eli Lilly and Company

M.D. Anderson Cancer Center

City of Hope National Medical Center

Investigators

Principal Investigator:	James Huang, MD	Memorial Sloan Kettering Cancer Center

More Information

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Additional Information:

Memorial Sloan-Kettering Cancer Center 

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
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