NCT00425750 · REGISTRY CONDITION SEARCH

Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2011-11-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Patient Response to Treatment

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: bortezomib
Drug: docetaxel
Other: laboratory biomarker analysis
Other: pharmacological study
label
Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment
description
1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
name
bortezomib
type
DRUG
arm Group Labels
Treatment
description
40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1.
name
docetaxel
type
DRUG
arm Group Labels
Treatment
description
Tissue and blood collection.
name
laboratory biomarker analysis
type
OTHER
arm Group Labels
Treatment
description
Blood collection.
name
pharmacological study
type
OTHER

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Patient Response to Treatment
time Frame
7.55 months (average duration, on study to off study)

secondary Outcomes

description
Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)
measure
Overall Survival
time Frame
7.55 months (average duration, on study to off study)
description
Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)
measure
Progression-free Survival
time Frame
7.55 months (average duration, on study to off study)

Full study description

brief Summary: 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.
detailed Description: OBJECTIVES: Primary * Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with bortezomib and docetaxel. Secondary * Determine the time to progression in patients treated with this regimen. * Determine the toxicity of this regimen. * Determine the duration of response in patients treated with this regimen. * Determine the overall survival and progression-free survival of these patients. * Determine 20S proteasome inhibition in peripheral blood mononuclear cells (PBMC) from these patients. * Determine the effect of bortezomib on NF-kB pathway in PBMC and serum samples. * Identify biomarkers of clinical response to bortezomib and docetaxel in PBMC and serum. * Determine quality of life, symptom burden, and physical function outcome in patients treated with this regimen. OUTLINE: This is a prospective, open-label, nonrandomized study. Patients receive docetaxel\* IV over 30 minutes and bortezomib IV on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Docetaxel is not administered on day 1 of course 1. Blood samples are collected at baseline, after bortezomib administration on day 1 of course 1, and at the completion of treatment. The pharmacodynamics and pharmacogenomics of bortezomib are assessed in peripheral blood mononuclear cells (PBMC) and serum. After completion of study treatment, patients are followed every 6 weeks for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Source references

references

citation
Chung 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
type
RESULT
citation
Chung 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
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice