Clinical trial NCT01025089: Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Thymoma
Thymic Carcinoma
Clinical Masaoka Stage II to IVA
Keywords: Cetuximab
Cisplatin
Cyclophosphamide
09-038
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: M.D. Anderson Cancer Center
name: City of Hope National Medical Center
First posted: 2009-12-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab
timeFrame: 2 years
measure: To measure the radiographic response rate to cetuximab alone after 4 weeks
timeFrame: 4 weeks
measure: To determine the radiographic response rate to CAP and cetuximab
timeFrame: 2 years
measure: To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab
timeFrame: 2 years
measure: To correlate percentage of pathologic response to unidimensional and volumetric radiographic response
timeFrame: 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
state: New York
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: