Clinical trial · Interventional
Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer
Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
NCT01333852CI-TRIAL-00016711METTAXterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial
Conditions
Conditions (2)
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin up to 2500mg/d | Drug | — | UNRESOLVED |
| paclitaxel 175mg/m² q21d | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel, placebo
- description
- Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
- interventionNames
- Drug: paclitaxel 175mg/m² q21d
- Drug: placebo
- type
- EXPERIMENTAL
- label
- Paclitaxel plus metformin
- description
- Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
- interventionNames
- Drug: metformin up to 2500mg/d
- Drug: paclitaxel 175mg/m² q21d
Primary outcomes (1)
- measure
- Disease control at week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Biopsy-proven head and neck squamous cell carcinoma * Ineligibility for curative intent therapy, e.g., surgery or radiation therapy * recurrent or stage IV disease * previous failure to platinum-based chemotherapy * measurable disease according to RECIST v1.1 * PS ECOG 0-2 Exclusion Criteria: * known hypersensitivity to metformin or paclitaxel * SNC metastasis * Acute or chronic infection
References
Publications (0)
Data not yet available
No reference posted for this study.