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Monoclonal Antibodies

Paclitaxel +/− Cixutumumab for Esophageal Cancer

Phase 2

Waitlist Available

Led By Steven J Cohen

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have received and progressed on one and only one line of prior systemic therapy for esophagus or esophagogastric cancer; this could have included one regimen for metastatic disease, or one regimen with radiotherapy for initially locally advanced disease; prior radiation therapy is permitted

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

Recent major surgery, hormonal therapy (other than replacement) or chemotherapy, within 4 weeks prior to entering the study or those who have not recovered from adverse events

Patients have received prior taxane or anti-insulin growth factor receptor (IGFR) therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well paclitaxel (a chemotherapy drug) works with or without cixutumumab (a protein-blocking drug) to treat patients with esophageal or gastroesophageal junction cancer that has spread to other parts of the body.

Who is the study for?

This trial is for adults with metastatic esophageal or gastroesophageal junction cancer who have measurable disease and have only had one prior systemic therapy. They must not be pregnant, agree to use contraception, and cannot have uncontrolled conditions like diabetes or a second active cancer. People who've had recent major surgery or certain treatments are excluded.

What is being tested?

The study is testing the effectiveness of paclitaxel chemotherapy with or without cixutumumab (which blocks proteins that may help cancer grow) in patients with advanced esophageal cancers. It's a randomized trial, meaning participants are randomly assigned to receive either both drugs or just paclitaxel.

What are the potential side effects?

Possible side effects include allergic reactions similar to those from compounds related to cixutumumab, blood sugar issues for diabetics, and typical chemotherapy-related effects such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I have had one treatment for esophagus cancer that has spread, which may have included radiation.

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I am able to get out of my bed or chair and move around.

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My kidney function is within the required range.

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I do not have a tumor in the area where my stomach meets my esophagus.

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My cancer originates from the upper part of my stomach or the area where my esophagus meets my stomach.

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My cancer returned within 6 months after initial treatment, counting as one treatment line.

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My stomach cancer has spread to the lower part of my esophagus.

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My cancer has spread from my esophagus or where my stomach meets my esophagus.

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My cancer is a type of adenocarcinoma that started in the lower part of my esophagus.

Exclusion Criteria

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

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I haven't had major surgery or certain cancer treatments in the last 4 weeks.

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I have previously been treated with taxane or anti-IGFR therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years for reporting.