Phase 2 N=5 Treatment

Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00293579 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Overall Response Rate — 0 patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pemetrexed (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University Comprehensive Cancer Center
Primary completion: May 2008

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	—

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.

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

View full record on ClinicalTrials.gov →

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.