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A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma

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: NCT04367909
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Xin-Hua Xu, China Three Gorges University, Yichang, China

Study Description
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Brief Summary:
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of TC Regimenwith or without nimotuzumab in recurrent metastatic oral squamous cell carcinoma. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Drug: Nimotuzumab Drug: Docetaxel Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Single-center, Randomized, Controlled Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
Actual Study Start Date : June 21, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nimotuzumab plus TC Regimen chemotherapy
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
 Drug: Nimotuzumab
Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.

Drug: Docetaxel
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Carboplatin
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
Active Comparator: TC Regimen chemotherapy
TC Regimen chemotherapy every 3 weeks
 Drug: Docetaxel
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Carboplatin
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Compare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy using RECIST 1.1. [ Time Frame: approximately 24 months ]
    PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.


Secondary Outcome Measures :
  1. Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy. [ Time Frame: approximately 24 months ]
    ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.

  2. Compare Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy [ Time Frame: approximately 24 months ]
    To compare the efficacy of the combination of Nimotuzumab plus TC Regimen chemotherapy versus TC Regimen chemotherapy in terms of overall survival (OS) in patients with recurrent metastatic oral squamous cell carcinoma. Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.

  3. Compare Disease Control Rate (DCR) between Nimotuzumab + TC Regimen and TC Regimen chemotherapy. [ Time Frame: approximately 24 months ]
    DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).

  4. Number of Participants who Experience Treatment Related Adverse Events (AEs). [ Time Frame: approximately 24 months ]
    All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. AEs graded using CTCAE (Version 4.0) criteria.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Volunteer to participate in clinical research; fully understand and know the research and sign informed consent.
  2. Age ≥18 years, and ≤75years , either sex.
  3. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
  4. Patients with distant metastasis and/or recurrence of oral squamous cell carcinoma (including gingival cancer, tongue cancer, lip cancer, buccal cancer, oral cancer, etc) diagnosed by histopathology (according to the 8th edition of AJCC).
  5. Unable to perform local treatment (including radiotherapy and surgery).
  6. Have at least one measurable lesion as defined by RECIST 1.1.
  7. Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present.
  8. Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
  9. Normal hematological function：absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency].
  10. Has a life expectancy of at ≥3 months.

Exclusion Criteria:

  1. ECOG PS >2.
  2. Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within three months.
  3. Patients who are receiving any other investigational agents within 30 days prior to entering the study.
  4. The tumor has metastasized to the brain and / or pia mater.
  5. History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years).

  6. Accompanied by other serious diseases, including but not limited to:

    Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP > 160mmhg or DBP > 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance.

  7. Those who are allergic to the drug or its components used in the program.
  8. Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
  9. Those who are not considered suitable for the study by the researchers.
  10. Unwilling to participate in this study or unable to sign informed consent.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04367909


Contacts
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Contact: Xinhua Xu, Master +8613986747496 ext +8613986747496 2732774352@qq.com
Contact: Yan Wang, Master +8615997550081 ext +8615997550081 wangyan82033@163.com

Locations
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China, Hubei
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University Recruiting
Yichang, Hubei, China, 443003
Contact: Xinhua Xu    +8613986747496 ext +8613986747496    2732774352@qq.com   
Sponsors and Collaborators
Xin-Hua Xu
More Information
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Responsible Party: Xin-Hua Xu, professor, China Three Gorges University, Yichang, China
ClinicalTrials.gov Identifier: NCT04367909    
Other Study ID Numbers: CTGU004
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
 Carboplatin
Docetaxel
Nimotuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological