Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
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|ClinicalTrials.gov Identifier: NCT01794845|
Recruitment Status : Terminated (Early termination due to lack of efficacy (overall response))
First Posted : February 20, 2013
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma Head and Neck Cancer Recurrent Disease||Drug: Erbitux Drug: Taxotere Radiation: Low Dose Fractionated Radiation Therapy||Phase 2|
The investigator's approach is based on the following reasons:
- Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
- LDFRT will render enhanced bax activation mediated mode of cell death.
- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
- The toxicity profile is expected to be minimal.
Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma|
|Actual Study Start Date :||June 3, 2013|
|Actual Primary Completion Date :||June 7, 2016|
|Actual Study Completion Date :||June 7, 2016|
Experimental: Erbitux, Taxotere, LD Fractionated RT
Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Other Name: Cetuximab
Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Other Name: Docetaxel
Radiation: Low Dose Fractionated Radiation Therapy
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Other Name: LDFRT
- Overall Response Rate (ORR) of Participants [ Time Frame: Up to 6 months from End of Treatment, about 9 months ]ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
- Number of Study Participants Experiencing Treatment-Related Toxicity [ Time Frame: Up to 6 years ]
Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:
- Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.
- Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.
- Estimated Progression-Free Survival (PFS) [ Time Frame: Up to 6 years ]Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.
- Estimated Overall Survival (OS) [ Time Frame: Up to 6 years ]Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).
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): NCT01794845
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Matthew C Abramowitz, MD||University of Miami|