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

Thymoma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01025089
• Other study ID #: 09-038
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Clinical Masaoka Stage II to IVA
• Thymic Carcinoma
• Thymoma
• Thymus Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	City of Hope Medical Center	Duarte	California
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Md Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	City of Hope National Medical Center, Eli Lilly and Company, M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years
Secondary	To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab		2 years
Secondary	To measure the radiographic response rate to cetuximab alone after 4 weeks		4 weeks
Secondary	To determine the radiographic response rate to CAP and cetuximab		2 years
Secondary	To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab		2 years
Secondary	To correlate percentage of pathologic response to unidimensional and volumetric radiographic response		2 years

External Links

•   Memorial Sloan-Kettering Cancer Center