Clinical trial · Interventional
Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
NCT01333696CI-TRIAL-00009646unknownPhase 2ClinicalTrials.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)
The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of 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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | 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
- 500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 6 weeks
Secondary outcomes (2)
- measure
- Median progression-free survival
- timeFrame
- 1 year
- measure
- Median overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age range: 18-65 years old * Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck * Prior exposure of at least one line of platinum-containing regimen * At least one site of measurable disease according to RECIST criteria * ECOG performance status 0-1 * Life expectancy of more than 3 months * Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L * Liver function: total bilirubin, ALT and AST \<1.5×UNL * Renal function: Cr\<1.5×UNL, CCR≧45ml/min Exclusion Criteria: * With curable treatment option * Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Significant active infection * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.