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Trial record 30 of 1118 for:    Oral Cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00095628
Recruitment Status : Completed
First Posted : November 8, 2004
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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 Drug: ispinesib
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Period Title: Overall Study
Started 21
Completed 20
Not Completed 1
Reason Not Completed
Disease progression prior to treatment             1
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
A total of 21 patients were enrolled onto the study. One patient was ineligible due to disease progression prior to treatment. So a total of 20 evaluable patients were analyzed
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  65.0%
>=65 years
7
  35.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Participants
Number Analyzed 20 participants
60
(41 to 75)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
3
  15.0%
Male
17
  85.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Canada 18
United States 2
1.Primary Outcome
Title Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)
Hide Description 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
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
20 eligible patients were analyzed
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description:

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Duration of Objective Response
Hide Description 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
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected because 0 participants showed a response.
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description:

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Clinical and Objective Stable Disease
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description:

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
5
4.Secondary Outcome
Title Median Overall Survival of SB-715992
Hide Description Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description:

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.8 to 7.8)
5.Secondary Outcome
Title Median Time to Progression
Hide Description Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description:

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: months
1.4
(1.3 to 2.3)
6.Other Pre-specified Outcome
Title 1 Year Overall Survival
Hide Description Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description:

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20
(8.3 to 48.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Ispinesib)
Hide Arm/Group Description

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.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

All-Cause Mortality
Treatment (Ispinesib)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Ispinesib)
Affected / at Risk (%) # Events
Total   6/20 (30.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia   2/20 (10.00%)  2
General disorders   
Edema face   1/20 (5.00%)  1
Infections and infestations   
Pneumonia   1/20 (5.00%)  1
Upper respiratory infection   1/20 (5.00%)  1
Injury, poisoning and procedural complications   
Tracheal hemorrhage   1/20 (5.00%)  1
Injury to superior vena cava   1/20 (5.00%)  1
Tracheal obstruction   1/20 (5.00%)  1
Investigations   
Leukopenia  [1]  1/20 (5.00%)  1
Neutropenia  [2]  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Anorexia   1/20 (5.00%)  1
Hyperkalemia   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   1/20 (5.00%)  1
Dyspnea   2/20 (10.00%)  2
Indicates events were collected by systematic assessment
[1]
White blood count decreased
[2]
Neutrophil count decreased
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Ispinesib)
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Anemia   6/20 (30.00%) 
Gastrointestinal disorders   
Nausea   9/20 (45.00%) 
Vomiting   3/20 (15.00%) 
General disorders   
Fatigue   5/20 (25.00%) 
Investigations   
Neutropenia  [1]  14/20 (70.00%) 
Leukopenia  [2]  15/20 (75.00%) 
Lymphopenia  [3]  9/20 (45.00%) 
Metabolism and nutrition disorders   
Hyponatremia   6/20 (30.00%) 
Hypoalbuminemia   3/20 (15.00%) 
Musculoskeletal and connective tissue disorders   
Bone pain   1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Injection site reaction   3/20 (15.00%) 
Indicates events were collected by systematic assessment
[1]
Neutrophil count decreased
[2]
White blood count decreased
[3]
Lymphocyte count decreased
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Eric Winquist
Organization: London Regional Cancer Centre
Phone: 519-685-8600 ext 53243
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095628     History of Changes
Other Study ID Numbers: NCI-2012-03091
PHL-031
6803
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2004
First Posted: November 8, 2004
Results First Submitted: June 19, 2015
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017