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Trastuzumab + Pertuzumab vs. Cetuximab + Irinotecan for Colorectal Cancer
Study Summary
This trial studies trastuzumab and pertuzumab compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer.
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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- This is not actually a screening criterion, but a step in the clinical trial process where participants are randomly assigned to different treatment groups.I've had a full physical exam and shared my medical history within the last 28 days.I have not had severe reactions to cancer drugs like irinotecan, pertuzumab, or trastuzumab.I have received HER-2 targeted therapy for colorectal cancer.My cancer has spread or grown to a point where surgery can't remove it.My colon or rectum cancer has spread and cannot be removed by surgery.My cancer does not have specific genetic changes in KRAS, NRAS, or BRAF genes.I have not used drugs targeting EGFR for my condition.I've had trastuzumab or pertuzumab for breast cancer before my advanced colorectal cancer.My tumor slides are available for HER-2 testing by a central lab.I have not received HER-2 targeted treatments for my colorectal cancer.My cancer has been confirmed to have high levels of HER-2.My colon or rectum cancer has spread and cannot be removed by surgery.You have had past or current conditions that make you more likely to have an allergic reaction.My cancer does not have specific genetic mutations in KRAS/NRAS or BRAF genes.My brain metastases have been treated and stable for over 30 days.I have no cancer history except for certain skin cancers or cancers that have been inactive and untreated for 2 years.I am willing to provide tissue samples for future research.My cancer has a specific mutation in the KRAS/NRAS or BRAF gene.I have had severe reactions to irinotecan or similar medications.I have had cancer before, but it was either skin cancer, early-stage cervical or breast cancer, or another low-grade cancer and I've been free of disease and treatment for two years.You are currently pregnant or breastfeeding.I have previously been treated with drugs targeting EGFR.I have not been treated with any drugs targeting EGFR.I have had at least one chemotherapy treatment for my advanced cancer that cannot be surgically removed.I am fully active or restricted in physically strenuous activity but can do light work.You do not have any known condition that may make you more susceptible to allergic reactions.The hospital or medical center where you are receiving treatment needs to have recently approved this study for you to participate.I can provide slides of my tumor for HER-2 testing.I do not have any untreated or uncontrolled illnesses.I finished my last cancer treatment at least 14 days ago.My cancer was tested for specific mutations in a certified lab.I have never had a severe reaction to irinotecan or similar medications.I am not currently on any cancer treatments not approved in this study.I do not have any uncontrolled illnesses.Registration for the HER2 testing is the first step
- Group 1: Arm I (pertuzumab, trastuzumab)
- Group 2: Arm II (cetuximab, irinotecan hydrochloride)
- 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 the protocols for HER-2 testing approved by the Federal Drug Administration?
"While there exists some evidence that HER-2 testing is secure, the lack of data validating its efficacy necessitates a score of 2."
What is the current size of the participant cohort in this investigation?
"This research is not currently enrolment patients. Initially posted on October 9th 2017, and last edited May 9th 2022; thus alternative studies need to be considered. There are 4310 trials which involve adenocarcinoma presently actively recruiting as well as 545 studies for HER-2 testing that are open for participants."
In what contexts is PER-2 testing typically utilized?
"HER-2 testing is typically a tool for handling small cell lung cancer (sclc) but can also be utilized to combat colorectal carcinoma, ovarian cancer and sarcoma."
Has there been any prior research conducted on the efficacy of HER-2 testing?
"The initial research on HER-2 testing transpired at Ospedale di Circolo e Fondazione Macchi in 1999, and to date there are 1742 trials that have been completed. Currently, 545 clinical studies are underway across the world with significant activity occuring in Bremerton, Washington."
Are researchers currently accepting new participants for this experiment?
"This trial is no longer actively recruiting patients, with the latest update dated to May 9th 2022. If you are in search of other clinical trials related to adenocarcinoma there are 4355 available and 545 for HER-2 testing."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
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