Phase 2
Completed N=5
Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Source: ClinicalTrials.gov NCT00293579 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Overall Response Rate — 0 patients
Summary
This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
— | — |
| SECONDARY Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer |
80; 20; 20 | — |
| SECONDARY Impact of Pemetrexed Chemotherapy on Quality of Life |
524; 335.5 | — |
| SECONDARY Overall Survival |
4.4 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced, metastatic, or recurrent head and neck cancers
- Poor risk patients with ECOG performance status of 2
Exclusion Criteria
- Prior treatment for recurrent or metastatic disease
- No clinical or radiological evidence of brain metatases
- Patients with bone only disease are not eligible
- Patients with pleural or peritoneal effusion as only manifestation of diesase
Data sourced from ClinicalTrials.gov (NCT00293579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.