Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Start date: Jun 1999 to Aug 6, 1999v13
  3. Primary completion date: Sep 2004v12
  4. Interventions: cetuximab (Drug), cisplatin (Drug) to cetuximab (Biological), cisplatin (Drug)v11
  5. Re-verified, no change to tracked fieldsv10
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  1. Interventions: cetuximab (Drug), chemotherapy (Procedure), cisplatin (Drug), monoclonal antibody therapy (Procedure), protein tyrosine kinase inhibitor… to cetuximab (Drug), cisplatin (Drug)v9
  2. 2 versions Re-verified since Nov 16, 2007, no change to tracked fieldsv7-v8
  3. Interventions: antibody therapy (Procedure), biological therapy (Procedure), cetuximab (Drug), chemotherapy (Procedure), cisplatin (Drug), enzyme… to cetuximab (Drug), chemotherapy (Procedure), cisplatin (Drug), monoclonal antibody therapy (Procedure), protein tyrosine kinase inhibitor…v6
  4. Re-verified, no change to tracked fieldsv5
  5. Lead sponsor: National Cancer Institute (NCI) to Eastern Cooperative Oncology Groupv4 Show 5 more changesShow less
    • Interventions: cetuximab (Drug), cisplatin (Drug) to antibody therapy (Procedure), biological therapy (Procedure), cetuximab (Drug), chemotherapy (Procedure), cisplatin (Drug), enzyme…
    • Collaborator revised
    • Publications: 1 to 3
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 4 words
  6. Re-verified, no change to tracked fieldsv3
  7. Trial status: Active, Not Recruiting to Completedv2
  1. Study First Submitted
  • 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.
Trial Details
NCT Number NCT00003809
Lead Sponsor Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Head and Neck Cancer
Related terms Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov