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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
Women must not be pregnant or breast-feeding due to potential harm to fetus from cixutumumab (IMC-A12) and paclitaxel; all females of childbearing potential must have a blood test or urine study within 48 hours prior to registration to rule out pregnancy
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
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

Study 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.Check my eligibility
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.See study design
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 am not pregnant or breastfeeding and have tested negative for pregnancy within 48 hours before signing up.
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I have had one treatment for esophagus cancer that has spread, which may have included radiation.
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If my treatment was changed due to side effects without cancer worsening, it counts as one treatment line.
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I am able to get out of my bed or chair and move around.
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I do not have an active cancer other than non-melanoma skin cancer.
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My blood sugar and A1C levels are within the required range.
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My cancer in the esophagus or where my stomach meets my esophagus is confirmed and has spread or come back.
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My kidney function is within the required range.
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My cancer is classified as adenocarcinoma, including certain types affecting the stomach and esophagus.
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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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I have a tumor at the junction of my stomach and esophagus.
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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.

Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Secondary outcome measures
Objective Response Rate
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (cixutumumab, paclitaxel)Experimental Treatment4 Interventions
Patients receive cixutumumab IV over 1 hour on days 1 and 15, and paclitaxel as in Arm I.
Group II: Arm I (paclitaxel)Experimental Treatment3 Interventions
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cixutumumab
2011
Completed Phase 2
~1410
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,181 Total Patients Enrolled
Steven J CohenPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Cixutumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01142388 — Phase 2
Esophageal Cancer Research Study Groups: Arm I (paclitaxel), Arm II (cixutumumab, paclitaxel)
Esophageal Cancer Clinical Trial 2023: Cixutumumab Highlights & Side Effects. Trial Name: NCT01142388 — Phase 2
Cixutumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01142388 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this research undertaking at present?

"At this juncture, the study is not presently seeking participants. The investigation was initially posted on September 21st 2010 and updated lastly on November 16th 2022. If you're interested in other trials, there are 4130 research projects enrolling those with relapse and 832 studies that require Paclitaxel patients."

Answered by AI

Has Paclitaxel been utilized in previous research efforts?

"Up to this point, 832 medical studies have been conducted in order to better understand Paclitaxel. As of today, 227 trials are classified as phase 3 and 45639 sites globally are currently running investigations related to the drug. The majority of those clinical trial databases for Paclitaxel happen to be based around Woolloongabba, Queensland."

Answered by AI

What is the aggregate amount of participants involved in this medical experiment?

"Recruitment for this medical trial has ceased. It was first listed on September 21st 2010, and most recently updated November 16th 2022. If you are seeking to join a different study, there are currently 4130 clinical trials actively recruiting participants with relapse and 832 trials for Paclitaxel available at the moment."

Answered by AI

How many venues are currently hosting this research endeavor?

"This clinical trial is currently seeking 100 patients, with recruitment taking place at the University of Wisconsin Hospital and Clinics in Madison, DuPage Medical Group - Joliet in Joliet, North Colorado Medical Center in Greeley, and many other sites."

Answered by AI

Has the U.S. Food and Drug Administration (FDA) sanctioned Paclitaxel?

"According to our internal assessment, paclitaxel's safety rating is 2 on a scale from 1 to 3. This evaluation was based on the fact that this particular trial is in Phase 2 - meaning there are some data points supporting its relative security but no evidence yet of efficacy."

Answered by AI

What maladies is Paclitaxel commonly employed to address?

"Paclitaxel is the usual line of attack for neoplasm metastasis, but it may also prove advantageous in treating Kaposi's Sarcoma, advanced directives and Fallopian tube cancer."

Answered by AI
~6 spots leftby Mar 2025