deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01064479

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Sponsor: M.D. Anderson Cancer Center

Conditions Metastatic Squamous Cell Carcinoma of the Hypopharynx Metastatic Squamous Cell Carcinoma of the Larynx Metastatic Squamous Cell Carcinoma of the Oral Cavity Metastatic Squamous Cell Carcinoma of the Oropharynx Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
Interventions Carboplatin Cisplatin Docetaxel Erlotinib Hydrochloride Laboratory Biomarker Analysis Pharmacological Study Placebo Quality-of-Life Assessment
Updated 15 times since 2017 Last updated: Jul 3, 2024 Started: Feb 5, 2010 Primary completion: Nov 3, 2020 Completion: Nov 3, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Metastatic Squamous Cell Carcinoma of the Hypopharynx and Metastatic Squamous Cell Carcinoma of the Larynx, this trial is completed. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 15 data snapshots since 2010. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Jun 2019 · 7 months · monthly snapshot~Jun 2019 – ~May 2020 · 11 months · monthly snapshot~May 2020 – ~Dec 2020 · 7 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshot~Feb 2022 – ~Sep 2022 · 7 months · monthly snapshot~Sep 2022 – ~Nov 2023 · 14 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jul 2024 — Aug 2024 [monthly]

    Completed PHASE2

  4. Nov 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Sep 2022 — Nov 2023 [monthly]

    Completed PHASE2

▶ Show 10 earlier versions

  1. Feb 2022 — Sep 2022 [monthly]

    Completed PHASE2

  2. Jan 2021 — Feb 2022 [monthly]

    Completed PHASE2

  3. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  4. May 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE2

  5. Jun 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Nov 2018 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

  7. Jun 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2

  8. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  9. Feb 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE2

  10. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Feb 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations