Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05041127|
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : December 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chordoma Metastatic Chordoma Unresectable Chordoma||Biological: Cetuximab Other: Questionnaire Administration||Phase 2|
• To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1.
- To evaluate response rate according to Choi criteria
- To evaluate the safety and tolerability of cetuximab for chordoma patients
- To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median).
- To evaluate the ratio of PFS on study compared to PFS from prior treatment
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma|
|Actual Study Start Date :||May 27, 2022|
|Estimated Primary Completion Date :||September 1, 2024|
|Estimated Study Completion Date :||September 1, 2024|
Experimental: Treatment (cetuximab)
Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
- Overall response rate [ Time Frame: through study completion, an average of 1 year ]Measured by Response Evaluation Criteria in Solid Tumors 1.1. Will be estimated based on a binomial portion expressed as percentage with 95% confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041127
|Contact: Anthony Conley, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anthony P. Conley, MD 713-796-3626 firstname.lastname@example.org|
|Principal Investigator: Anthony P. Conley, MD|
|Principal Investigator:||Anthony P Conley, MD||M.D. Anderson Cancer Center|