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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
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 belowSelect...
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.
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
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
13,717 Previous Clinical Trials
40,953,269 Total Patients Enrolled
Steven J CohenPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding and have tested negative for pregnancy within 48 hours before signing up.I have had one treatment for esophagus cancer that has spread, which may have included radiation.If my treatment was changed due to side effects without cancer worsening, it counts as one treatment line.I am able to get out of my bed or chair and move around.I do not have an active cancer other than non-melanoma skin cancer.My blood sugar and A1C levels are within the required range.My diabetes is under control with fasting glucose <= 160 mg/dL and A1C <= 7%.My cancer in the esophagus or where my stomach meets my esophagus is confirmed and has spread or come back.I do not have serious infections, HIV, or uncontrolled heart problems.My kidney function is within the required range.My cancer is classified as adenocarcinoma, including certain types affecting the stomach and esophagus.I do not have a tumor in the area where my stomach meets my esophagus.I haven't had major surgery or certain cancer treatments in the last 4 weeks.My cancer originates from the upper part of my stomach or the area where my esophagus meets my stomach.My cancer returned within 6 months after initial treatment, counting as one treatment line.I have a tumor at the junction of my stomach and esophagus.Your doctor expects you to live for at least 12 more weeks.My stomach cancer has spread to the lower part of my esophagus.My cancer has spread from my esophagus or where my stomach meets my esophagus.You should not have any of these conditions:You have had allergic reactions to drugs similar to cixutumumab (IMC-A12) in the past.I have previously been treated with taxane or anti-IGFR therapy.My cancer is a type of adenocarcinoma that started in the lower part of my esophagus.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel)
- Group 2: Arm II (cixutumumab, paclitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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