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

NCT00095628 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-03091PHL-0316803N01CM62203
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity

Outcome Measures

Primary Outcomes (1)

• Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion

  Up to 18 months

Secondary Outcomes (4)

• Duration of Objective Response

  Up to 18 months

• Number of Participants With Clinical and Objective Stable Disease

  Up to 18 months

• Median Overall Survival of SB-715992

  Up to 18 months

• Median Time to Progression

  Up to 18 months

Other Outcomes (1)

• 1 Year Overall Survival

  12 months

Study Arms (1)

Treatment (ispinesib)

EXPERIMENTAL

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.

Drug: ispinesib; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

ispinesib DRUG

Given IV

Also known as: CK0238273, SB-715992

Treatment (ispinesib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (ispinesib)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (ispinesib)

Eligibility Criteria

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

You may qualify if:

• 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.
• ECOG performance status 0,1, or 2
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,000/uL
• Total bilirubin =\< 1.5 X institutional upper limit of normal

You may not qualify if:

• 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
• Miscellaneous: amiodarone\*, grapefruit juice, bitter orange
• Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited
• Inducers of CYP3A4:
• Anticonvulsants: phenytoin, carbamazepine, Phenobarbital, oxcarbazepine
• Antibiotics: rifampin, rifabutin, rifapentine

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

ispinesib; CK0238273

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. Eric Winquist
• Organization: London Regional Cancer Centre

eric.winquist@lhsc.on.ca

519-685-8600

Study Officials

• Eric Winquist

  Princess Margaret Hospital Phase 2 Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2004
• First Posted: November 8, 2004
• Study Start: January 1, 2005
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

CA (1)