Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (CACTUX)
|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: NCT02270814|
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Cancer of the Head and Neck||Drug: nab-paclitaxel Drug: Cisplatin Drug: Carboplatin Biological: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Single Arm Trial of Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma (HNSCC)|
|Actual Study Start Date :||February 2, 2015|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: CACTUX: nab-paclitaxel, cisplatin (or carboplatin), cetuximab
Up to 6 cycles of CACTUX may be given. The CACTUX regimen consists of:
After the completion of 6 cycles of CACTUX, maintenance therapy will be given and consists of:
Other Name: Erbitux®
- Progression-free survival (PFS) - with first line therapy [ Time Frame: 8 months (estimated median length of treatment) ]PFS is defined as the time from randomization to first radiologic confirmation of disease progression, or death from any cause.
- Overall survival (OS) [ Time Frame: Until death (estimated 24 months) ]OS is defined as the time from randomization to death.
- Overall response rate [ Time Frame: 8 months (estimated median length of treatment) ]
Overall response rate = complete response + partial response
Evaluated using RECIST 1.1.
- Grade 3 and 4 adverse events [ Time Frame: 9 months (28 days from last dose of study drug with estimated median length of treatment of 8 months) ]
Adverse events will be recorded from the date of first dose of study drug (nab-paclitaxel) until 28 days after the last dose of study drug.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
- Quality of life [ Time Frame: Baseline, End of cycle 2, End of cycle 6, and End of treatment (estimated median length of treatment is 8 months) ]
Using the EORTC QLQ-C30, MDADI, FACT-H&N, and FACT/GOG-NTX-4.
- The EORTC-QLQ-C30 has a total score, one general QOL and one "within the last week" subscale, as well as a single "overall general health" item and a single "overall QOL" item. Scale is from 1-4 with 1 = not at all and 4 = very much on 28 questions. The scale is from 1-7 on 2 questions with 1 = very poor and 7 = excellent.
- The MDADI has 1 global dysphagia item, physical, function and emotional subscales and one summary scale, which is the sum of the 3 subscales rescaled to 0-100.
- The FACT instruments have four subscales (physical, social, emotional and functional), as well as 11-12 head and neck cancer-specific questions. The scale goes from 1-4 with 1 = not at all and 4 = very much.
- Progression-free survival (PFS) - with maintenance therapy [ Time Frame: 8 months (estimated median length of treatment) ]PFS on maintenance therapy is defined as time from first dose of maintenance therapy to first radiologic confirmation of disease progression, or death from any cause.
- Disease control [ Time Frame: 8 months (estimated median length of treatment) ]
Disease control = complete response + partial response + stable disease
Evaluated using RECIST 1.1
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): NCT02270814
|Contact: Douglas R Adkins, M.D.||firstname.lastname@example.org|
|United States, Arkansas|
|University of Arkansas for Medical Sciences||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Omar Atiq, M.D. 870-535-2800 email@example.com|
|Principal Investigator: Omar Atiq, M.D.|
|Sub-Investigator: Laura Hutchins, M.D.|
|Sub-Investigator: Konstantinos Arnaoutakis, M.D.|
|Sub-Investigator: Issam Makhoul, M.D.|
|Sub-Investigator: Rangaswamy Govindarajan, M.D.|
|Sub-Investigator: Fade Mahmoud, M.D.|
|Sub-Investigator: Peter Emanuel, M.D.|
|Sub-Investigator: Natasa Milojkovic, M.D.|
|Sub-Investigator: Pooja Motwani, M.D.|
|Sub-Investigator: Liudmila Schafer, M.D.|
|United States, Mississippi|
|University of Mississippi Medical Center||Recruiting|
|Jackson, Mississippi, United States, 39216|
|Contact: Robert Hamilton, M.D. 601-984-5590|
|Principal Investigator: Robert Hamilton, M.D.|
|Sub-Investigator: James T Thigpen, M.D.|
|Sub-Investigator: Barbara Craft, M.D.|
|Sub-Investigator: Louis Puneky, M.D.|
|Sub-Investigator: Jennifer Eubanks, M.D.|
|Sub-Investigator: Natale Sheehan, M.D.|
|Sub-Investigator: John C Henegan, M.D.|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Douglas R Adkins, M.D. 314-362-5654 firstname.lastname@example.org|
|Principal Investigator: Douglas Adkins, M.D.|
|Sub-Investigator: Tanya Wildes, M.D.|
|Sub-Investigator: Peter Oppelt, M.D.|
|Principal Investigator:||Douglas R Adkins, M.D.||Washington University School of Medicine|