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Monoclonal Antibodies

Chemotherapy + Cetuximab for Thymic Cancer

Phase 2

Waitlist Available

Led By James Huang, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma

No prior treatment with cetuximab

Must not have

Evidence of distant metastatic disease (Masaoka stage IVB)

Thymic carcinoid

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the addition of the drug cetuximab to standard chemotherapy for thymoma and thymic carcinoma. They will look at how well it works and if there are any side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to cetuximab; nausea; hair loss; mouth sores from chemotherapy drugs; increased risk of infection due to low blood counts; kidney and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had any treatment for thymoma, except for a biopsy.

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I have never been treated with cetuximab.

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My thymoma/thymic carcinoma is at an advanced stage, possibly spreading to nearby areas.

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I am older than 18 years.

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

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

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My kidney function is good, with creatinine levels at or below 1.3 mg/dl.

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My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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I have been diagnosed with thymic carcinoid.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cetuximab, Cisplatin, Doxorubicin & CyclophosphamideExperimental Treatment1 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.

0 / 12Eligibility criteria met