Clinical trial · Interventional
Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors
NCT00201812CI-TRIAL-00030690completedPhase 1ClinicalTrials.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)
To determine the safety and efficacy of the combination of Etanercept and Docetaxel in patients with advanced solid tumors for which there is no standard treatment.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Etanercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.
- timeFrame
- up to 4 years
Secondary outcomes (3)
- measure
- Characterize toxicities of weekly docetaxel when administered weekly to patients with solid malignancies to determine if co-administration of etanercept can result in higher tolerated doses of docetaxel.
- timeFrame
- up to 4 years
- measure
- Determine if weekly docetaxel administration is associated with increased expression of TNF and if inactivation of TNF by etanercept is associated with a decrease in the rate of moderate to severe asthenia.
- timeFrame
- up to 4 years
- measure
- Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have pathologically or cytologically confirmed advanced solid malignancy for which there is no standard treatment exists. * Solid malignancy that has persisted or recurred following prior therapy or advanced solid malignancy for which docetaxel is considered an acceptable first line treatment option: * Non-Small Cell Lung * Breast * Head and Neck * Esophageal * Stomach * Ovarian carcinomas * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 * Life expectancy of at least 12 weeks. * Must have adequate organ function * Peripheral Neuropathy must be less than Grade 2
References
Publications (1)
- RESULTMonk JP, Phillips G, Waite R, Kuhn J, Schaaf LJ, Otterson GA, Guttridge D, Rhoades C, Shah M, Criswell T, Caligiuri MA, Villalona-Calero MA. Assessment of tumor necrosis factor alpha blockade as an intervention to improve tolerability of dose-intensive chemotherapy in cancer patients. J Clin Oncol. 2006 Apr 20;24(12):1852-9. doi: 10.1200/JCO.2005.04.2838. PMID 16622259