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

NCT00425750 | Completed Phase 2 Results DMC

• 5 other identifiers: VICC HN 0501P30CA068485VU-VICC-HN-0501MILLENIUM-X05170VU-VICC-IRB-050183
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

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.

Conditions

Head and Neck Cancer

Keywords

stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx

Outcome Measures

Primary Outcomes (1)

• Patient Response to Treatment

  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.

  7.55 months (average duration, on study to off study)

Secondary Outcomes (2)

• Overall Survival

  7.55 months (average duration, on study to off study)

• Progression-free Survival

  7.55 months (average duration, on study to off study)

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: bortezomib; Drug: docetaxel; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

bortezomib DRUG

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.

Treatment

docetaxel DRUG

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.

Treatment

laboratory biomarker analysis OTHER

Tissue and blood collection.

Treatment

pharmacological study OTHER

Blood collection.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Jennie Stuart Medical Center

Hopkinsville, Kentucky, 42240-2400, United States

Location

Purchase Cancer Group - Paducah

Paducah, Kentucky, 42001, United States

Location

Tennessee Plateau Oncology - Crossville

Crossville, Tennessee, 38555, United States

Location

West Tennessee Cancer Center at Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Baptist Regional Cancer Center at Baptist Riverside

Knoxville, Tennessee, 37901, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208-3599, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (2)

• 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 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Bortezomib; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Barbara Murphy, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

615-343-4677

Study Officials

• Barbara Murphy, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 16, 2011
• Results First Posted: April 4, 2011

Record last verified: 2011-11

Locations

US (7)