Chemotherapy + Cetuximab for Thymic Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by James Huang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

James Huang, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed or recurrent thymoma or thymic carcinoma, who haven't had previous treatments. They must have a good performance status, normal organ function, and be medically fit for surgery. Pregnant women, HIV-positive patients on certain therapies, and those with other recent cancers or distant metastases cannot participate.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

My thymoma or thymic carcinoma diagnosis is confirmed by specific cancer centers.

I am fit for surgery.

Exclusion Criteria

I have not had cancer, except for skin cancer or cervical pre-cancer, in the last 5 years.

I am HIV-positive and not on anti-retroviral therapy.

I am taking medications that affect CYP3A4 enzyme activity.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Cisplatin (Alkylating agents)
• Cyclophosphamide (Anti-metabolites)
• Doxorubicin (Anti-tumor antibiotic)
• Surgical Resection (Surgery)

Trial Overview The study tests the effects of combining cetuximab with traditional chemotherapy (cisplatin, doxorubicin & cyclophosphamide) before surgical removal in advanced stage thymoma or thymic carcinoma patients. It also examines genetic changes in tumors related to cetuximab's effectiveness.

Participant Groups

Group I: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

City of Hope National Medical Center

Collaborator

Trials

17

Recruited

8,900+