At a glance
ClinicalIndex Comparison Record- ✓Histologically documented progressive squamous cell head and neck cancer with or without metastases, not amenable to curative treatment, or documented patient refusal of curative treatment
- ✓ECOG performance status 0–2
- ✓Measurable disease by CT scan per RECIST v1.1
- ✓Age ≥18 years
- ✕Prior cytotoxic chemotherapy in the recurrent/metastatic setting
- ✕Untreated or progressive brain metastases, spinal cord compression, or carcinomatous meningitis
- ✕Gastrointestinal abnormalities causing impaired absorption precluding oral medication administration
- ✕Serious uncontrolled medical disorder or active infection impairing ability to receive study treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center Open Label Single Arm Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Palbociclib and Carboplatin for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 21 participants across 3 sites.
Detailed Summary
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of palbociclib (Ibrance) plus carboplatin in patients with metastatic head and neck squamous cell cancer.
Study Details
Timeline
Interventions
Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days Maintenance Palbociclib: Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days
Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days