Clinical trial · Interventional
Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Phase II Trial of Combination Weekly Bortezomib (VELCADE) and Docetaxel (TAXOTERE) in Patients With Recurrent and/ or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00425750CI-TRIAL-00005771completedPhase 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)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel works in treating patients with recurrent or metastatic head and neck cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Docetaxel (40 mg/m2) IV Infusion over 30 minutes every 3 weeks (Day 1 and 8 of 21 day cycle)except the first dose is held on Day 1 of Cycle 1. Bortezomib (1.6mg/m2) IV 3-5 second push every 3 weeks (Day 1 and 8 of 21 day cycle).Bortezomib is given as a single agent only on Day 1 of Cycle 1.
- interventionNames
- Drug: bortezomib
- Drug: docetaxel
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Patient Response to Treatment
- timeFrame
- 7.55 months (average duration, on study to off study)
- description
- Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Recurrent or metastatic disease * Measurable disease * Not a candidate for curative therapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm³ * AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria: * AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * Bilirubin normal * Creatinine clearance ≤ 2.0 mg/dL * No peripheral neuropathy ≥ grade 2 within the past 28 days * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No electrocardiographic evidence of acute ischemia or active conduction system abnormalities * No known hypersensitivity to bortezomib, boron, or mannitol * No known severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No serious medical or psychiatric illness that would preclude study participation * No other malignancy within the past 3 years except for early-stage nonmelanomatous skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment PRIOR CONCURRENT THERAPY: * No prior chemotherapy for recurrent or metastatic disease * At least 28 days since prior and no other concurrent investigational drugs * No other concurrent anticancer therapy * No other concurrent chemotherapy * No concurrent complementary or herbal medicine * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
References
Publications (2)
- RESULTChung CH, Aulino J, Muldowney NJ, Hatakeyama H, Baumann J, Burkey B, Netterville J, Sinard R, Yarbrough WG, Cmelak AJ, Slebos RJ, Shyr Y, Parker J, Gilbert J, Murphy BA. Nuclear factor-kappa B pathway and response in a phase II trial of bortezomib and docetaxel in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2010 Apr;21(4):864-870. doi: 10.1093/annonc/mdp390. Epub 2009 Oct 22. PMID 19850643
- DERIVEDChung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31. PMID 25081901