Study on Paclitaxel With or Without Cixutumumab for Treating Metastatic Esophageal or Gastroesophageal Junction Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01142388
This clinical trial is testing whether adding the drug cixutumumab to the chemotherapy drug paclitaxel can improve treatment outcomes for patients with esophageal or gastroesophageal junction cancer that has spread to other parts of the body.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining the chemotherapy drug paclitaxel with another drug called cixutumumab can help control esophageal or gastroesophageal junction cancer that has spread. Paclitaxel works by stopping cancer cells from growing and spreading, while cixutumumab may help by blocking a protein that cancer cells need to grow. The study will compare the effects of paclitaxel alone versus paclitaxel with cixutumumab to see which is more effective in stopping the cancer from progressing.
Description
The study has two main goals: to see if the combination of paclitaxel and cixutumumab can help patients live longer without the cancer getting worse, and to compare the overall survival rates between the two treatment groups. Researchers will also look at how well the cancer responds to the treatments and any side effects that occur. Patients will be randomly assigned to one of two groups: one group will receive paclitaxel alone, and the other group will receive both paclitaxel and cixutumumab. Both treatments are given through an IV, and the cycles repeat every 28 days as long as the treatment is effective and side effects are manageable. After finishing the study treatment, patients will have follow-up visits every three months for two years.
Eligibility Criteria
Inclusion Criteria
- Life expectancy of at least 12 weeks.
- Women must not be pregnant or breastfeeding and must use effective birth control during the study and for three months after the last dose.
- Men must also agree to use effective contraception during the study and for three months after.
- Must have cancer that can be measured and has spread from the esophagus or gastroesophageal junction.
- Must have received and progressed on one previous treatment for this type of cancer.
- Must be in good overall health with a performance status score of 0 to 2.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Must not have any other active cancers, except for certain skin cancers.
Exclusion Criteria
- Have received prior treatment with taxane drugs or anti-IGFR therapy.
- Have poorly controlled diabetes or other serious medical conditions that could make the study unsafe.
- Have had recent major surgery or other treatments that have not fully healed.
- Have a history of severe allergic reactions to similar drugs.
- Have psychiatric conditions that prevent understanding the study.
- Have active infections or serious heart conditions that are not well-controlled.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Stanford Cancer Institute Palo Alto | 94304 | Palo Alto | California |
| The Medical Center of Aurora | 80012 | Aurora | Colorado |
| Boulder Community Foothills Hospital | 80303 | Boulder | Colorado |
| Penrose-Saint Francis Healthcare | 80907 | Colorado Springs | Colorado |
| AdventHealth Porter | 80210 | Denver | Colorado |
| Presbyterian - Saint Lukes Medical Center - Health One | 80218 | Denver | Colorado |
| Saint Joseph Hospital - Cancer Centers of Colorado | 80218 | Denver | Colorado |
| Rose Medical Center | 80220 | Denver | Colorado |
| Western States Cancer Research NCORP | 80222 | Denver | Colorado |
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