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PD 0332991 + Cetuximab for Squamous Cell Carcinoma
Study Summary
This trial is testing a new cancer drug to see what dose is safe and what side effects it causes when combined with another cancer drug.
Timeline
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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- You have received treatment with cetuximab in the past for your condition.You are currently taking medications called proton pump inhibitors.You have had allergic reactions to similar drugs like PD 0332991 or cetuximab in the past.You are not currently taking any experimental drugs.
- Group 1: Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
- Group 2: Phase I: Dose Level 2
- Group 3: Phase I: Dose Level 1
- Group 4: Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
- Group 5: Phase II Arm 3:
- 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
What therapeutic results are investigators hoping to achieve through this clinical trial?
"This trial, which is expected to culminate in Phase I results after 6 months of observation, aims to measure efficacy by Overall Response Rate. Additionally, NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used as a metric in order to gauge the frequency and intensity of PD 0332991 related adverse events occurring on 10% or more participants at any point throughout the study; cetuximab-related adverse events with similar criteria are also observed during Phase II."
Are there any established precedents for Cetuximab trials?
"Since 2007 when the first trial of cetuximab was conducted at Saint Bartholomew's Hospital, 445 studies have been completed. Currently there are 248 active trials worldwide; many located in and around Missouri's largest city - St Louis."
Is it possible for participants to still join this experiment?
"The clinicaltrials.gov information attests that this study is not currently recruiting patients, having been initially posted on June 17th 2014 and last edited on November 1st 2022. At the moment, however, there are 1018 other medical trials which require enrolment of volunteers."
How extensive is the enrollment for this clinical trial?
"Unfortunately, recruitment for this investigation has been paused. Originally posted on June 17th 2014 and most recently modified November 1st 2022, the study is currently not searching for participants. However, those interested in other clinical trials can view 770 studies actively admitting patients with carcinoma, squamous cell and 248 research initiatives utilizing Cetuximab that are still accepting recruits."
Which medical conditions are typically treated with Cetuximab?
"Cetuximab can be used to treat radiation therapy, metastatic squamous cell carcinoma of the head and neck (hnscc), as well as other forms of squamous cell carcinoma."
What is the overall number of healthcare centers currently administering this experiment?
"This clinical trial is enlisting patients from Washington University School of Medicine in Saint Louis, Winship Cancer Institute at Emory University located in Atlanta and the University of Michigan Health System based in Ann Arbor. Additionally, there are 5 other locations involved with this study."
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