Clinical trial · Interventional
Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
NCT00293579CI-TRIAL-00043288completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- description
- pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to 3 years
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcomes (3)
- measure
- Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDUrba S, van Herpen CM, Sahoo TP, Shin DM, Licitra L, Mezei K, Reuter C, Hitt R, Russo F, Chang SC, Hossain AM, Frimodt-Moller B, Koustenis A, Hong RL. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. Cancer. 2012 Oct 1;118(19):4694-705. doi: 10.1002/cncr.27449. Epub 2012 Mar 20. PMID 22434360