Trials / Completed
CompletedNCT00095628
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ispinesib | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2010-07-01
- Completion
- 2010-07-01
- First posted
- 2004-11-08
- Last updated
- 2017-03-06
- Results posted
- 2017-03-06
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00095628. Inclusion in this directory is not an endorsement.