Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03174275 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor 2 versions Re-verified since Feb 5, 2025, no change to tracked fieldsv18-v19
  2. Minor Study completion date: Dec 2, 2026 to Feb 2, 2027v17
  3. Notable Results first posted: Feb 8, 2023v16
  4. Minor Re-verified, no change to tracked fieldsv15
  5. Minor Secondary endpoints revised (5)
    • Primary endpoint revised
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Primary completion date changed from estimate of May 2, 2022 to Feb 2, 2022
    • Study completion date: May 2, 2027 to Dec 2, 2026
    v13
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v12
  3. Notable Primary completion date: Sep 1, 2021 to May 2, 2022
    • Study completion date: Sep 1, 2026 to May 2, 2027
    v11
  4. Minor Re-verified, no change to tracked fieldsv10
  5. Minor Study sites: 1 to 2v9
  6. Minor Re-verified, no change to tracked fieldsv8
  7. Minor Eligibility criteria expanded, about 4 wordsv7
  8. Minor Eligibility criteria expanded, about 4 wordsv6
  9. Minor Re-verified, no change to tracked fieldsv5
  10. Minor Study description revisedv4
  11. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2018 to Dec 19, 2017
    • Site details revised
    v3
  12. Notable Start date: Jun 1, 2017 to Jan 15, 2018
    • Eligibility criteria expanded, about 9 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Participants in this study have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This is called locally-advanced SCCHN. These participants are eligible for surgery. Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage, high rates of avoiding radiation and its side effects, high cure rate and good quality of life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If the participants are not on this study they would be receiving radiation as it is standard treatment of their cancer. In the last study with a similar regimen, about a third of cancers had a pathologic complete response with the first part of the study. This means that the chemotherapy had killed the cancer. The investigators are trying to improve the regimen further with a goal of increasing this rate of complete response to the first part of therapy. The investigators also hope that by improving results in the first part, that more people will be cured and that long term quality of life (especially speech and swallowing) will be improved, both compared to standard therapies and to the last study. Doctors do not know how this therapy will effect the participants. There is no guarantee that this study will benefit the participants. The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and a third targeted anti-cancer drug. In this study the investigators are testing the combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound paclitaxel has been shown to be more active against other types of squamous cancers than regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to fight the cancer. Doctors hope that combining Durvalumab with 2 chemotherapy drugs will be effective in treating SCCHN. Durvalumab on its own has been studied in patients with SCCHN and initial results have shown that some subjects' cancer has responded to it. The purpose of this study is to test a combination of chemotherapy to hopefully both increase the number of subjects that respond to therapy while also decreasing the number of side effects that subjects experience.
Trial Details
NCT Number NCT03174275
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: AstraZeneca, Celgene
Conditions
(from sponsor)
Carcinoma, Squamous Cell, Oral Cancer, Oropharynx Cancer, Larynx Cancer, Lip Cancer, Esophageal Cancer
Related terms Carcinoma, Squamous Cell, Esophageal Neoplasms, Laryngeal Neoplasms, Lip Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov