Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
Primary Purpose
Thymoma, Thymic Carcinoma, Clinical Masaoka Stage II to IVA
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Thymoma focused on measuring Cetuximab, Cisplatin, Cyclophosphamide, 09-038
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
Sites / Locations
- City of Hope Medical Center
- Memorial Sloan Kettering at Basking Ridge
- Memorial Sloan Kettering Cancer Center @ Suffolk
- Memorial Sloan Kettering West Harrison
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering at Mercy Medical Center
- Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
- Md Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab
To measure the radiographic response rate to cetuximab alone after 4 weeks
To determine the radiographic response rate to CAP and cetuximab
To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab
To correlate percentage of pathologic response to unidimensional and volumetric radiographic response
Full Information
NCT ID
NCT01025089
First Posted
December 2, 2009
Last Updated
May 30, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Eli Lilly and Company, M.D. Anderson Cancer Center, City of Hope National Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01025089
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Eli Lilly and Company, M.D. Anderson Cancer Center, City of Hope National Medical Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Thymic Carcinoma, Clinical Masaoka Stage II to IVA
Keywords
Cetuximab, Cisplatin, Cyclophosphamide, 09-038
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab
Time Frame
2 years
Title
To measure the radiographic response rate to cetuximab alone after 4 weeks
Time Frame
4 weeks
Title
To determine the radiographic response rate to CAP and cetuximab
Time Frame
2 years
Title
To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab
Time Frame
2 years
Title
To correlate percentage of pathologic response to unidimensional and volumetric radiographic response
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Huang, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center
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Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
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