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SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

A Phase 2 Study of SB-715992 in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT00095628•National Cancer Institute (NCI)

Summary

This phase II trial is studying how well SB-715992 works in treating patients with recurrent or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the antitumor activity of SB-715992 in recurrent and/or metastatic squamous cell carcinoma of the head and neck using objective response rates (partial and complete responses). SECONDARY OBJECTIVES: I. To determine the duration of objective response, rate and duration of stable disease, progression-free, median and overall survival rates of SB-715992 in recurrent and/or metastatic squamous cell carcinoma of the head and neck. II. To document the safety and tolerability of SB-715992 in recurrent and/or metastatic squamous cell carcinoma of the head and neck. III. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck that is recurrent or metastatic; with the exception of the nasopharynx, all primary sites (including oral cavity, oropharynx, hypopharynx, and larynx) will be eligible; MedDRA disease terms:
•* Oral neoplasms NOS, 10031008
•* Oropharyngeal cancer recurrent, 10031098
•* Hypopharyngeal cancer recurrent, 10021044
•* Laryngeal cancer recurrent, 10023828
•* Maxillofacial sinus neoplasm, 10026956
•* Head and neck, 90002024
•Patients may have had a maximum of one prior chemotherapy regimen for recurrent or metastatic disease; patients may enter this study and receive SB-715992 as their first-line therapy for recurrent and/or metastatic disease; prior platinum-based chemotherapy delivered concurrently with radiotherapy, or prior platinum-based induction chemotherapy, is allowed; there must be at least a 4 week interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy - please contact the Principal Investigator (Dr. E. Winquist) PRIOR to registration if questions arise about the interpretation of this criterion; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
•Life expectancy of greater than 12 weeks.
+13 more criteria

Exclusion Criteria

•Patients with non-squamous cell carcinomas of the head and neck or nasopharyngeal cancer
•Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from AEs due to agents administered more than 4 weeks earlier
•Patients may not have received any other investigational agents within 28 days of study entry
•Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study
•The following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/substances within 14 days (\>= 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
•* Inhibitors of CYP3A4:
•* Antibiotics: clarithromycin, erythromycin, troleandomycin
•* Antifungals: itraconazole, ketoconazole, fluconazole (doses \> 200 mg/day), voriconazole
•* Antidepressants: nefazodone, fluovoxamine
•* Calcium channel blockers: verapamil, diltiazem
+10 more criteria

Locations (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, Canada

Key Dates

Start Date

January 1, 2005

Primary Completion Date

July 1, 2010

Completion Date

July 1, 2010

Last Updated

March 6, 2017

Enrollment

ACTUAL participants

Conditions

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the OropharynxStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Interventions

ispinesib

DRUG

laboratory biomarker analysis

OTHER

pharmacological study

OTHER

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COMPLETEDPHASE1

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

Exclusion Criteria

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