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Paclitaxel +/− Cixutumumab for Esophageal Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm I (paclitaxel)
- Group 2: Arm II (cixutumumab, paclitaxel)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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