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SB-715992 in Treating Patients With Advanced or Metastatic Colorectal 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: NCT00103311
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IIIA Colon Cancer
Stage IIIA Rectal Cancer
Stage IIIB Colon Cancer
Stage IIIB Rectal Cancer
Stage IIIC Colon Cancer
Stage IIIC Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions Drug: ispinesib
Other: laboratory biomarker analysis
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Patients receive SB-715992 IV at 18 mg/m2 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

Period Title: Overall Study
Started 33 31
Completed 29 30
Not Completed 4 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             2             1
Adverse Event             1             0
Arm/Group Title Arm I Arm II Total
Hide Arm/Group Description

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Patients receive SB-715992 IV at 18 mg/m2 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

Total of all reporting groups
Overall Number of Baseline Participants 33 31 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants 31 participants 64 participants
59
(28 to 82)
60
(35 to 80)
59
(28 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
Female
14
  42.4%
13
  41.9%
27
  42.2%
Male
19
  57.6%
18
  58.1%
37
  57.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 31 participants 64 participants
33 31 64
1.Primary Outcome
Title Objective Response (CR or PR) as Determined by the RECIST Criteria
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 lesions; Overall Response (OR) = CR + PR
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Patients receive SB-715992 IV at 18 mg/m2 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

Overall Number of Participants Analyzed 33 31
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Progression-free Survival
Hide Description Will be estimated using the product-limit method of Kaplan and Meier by arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From the date of registration to the date of documented PSA progression, assessed up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Patients receive SB-715992 IV at 18 mg/m2 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

Overall Number of Participants Analyzed 33 31
Median (95% Confidence Interval)
Unit of Measure: weeks
7.0
(6.3 to 7.3)
5.3
(5.0 to 5.9)
3.Secondary Outcome
Title Overall Survival
Hide Description Will be estimated using the product-limit method of Kaplan and Meier by arm.
Time Frame From the date of registration to the date of death, assessed up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Patients receive SB-715992 IV at 18 mg/m2 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

Overall Number of Participants Analyzed 33 31
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(2.5 to 8.2)
4.5
(3.7 to 7.0)
Time Frame Adverse events were over a period of 4 years.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Patients receive SB-715992 IV at 18 mg/m2 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

All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/33 (42.42%)      13/31 (41.94%)    
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Hemoglobin decreased * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  3/33 (9.09%)  4 1/31 (3.23%)  1
Ileal obstruction * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Nausea * 1  4/33 (12.12%)  5 1/31 (3.23%)  1
Rectal hemorrhage * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Small intestinal stenosis * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Vomiting * 1  3/33 (9.09%)  3 1/31 (3.23%)  1
General disorders     
Death * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Disease progression * 1  2/33 (6.06%)  2 4/31 (12.90%)  4
Fatigue * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Fever * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Multi-organ failure * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Hepatobiliary disorders     
Gallbladder obstruction * 1  0/33 (0.00%)  0 2/31 (6.45%)  2
Infections and infestations     
Catheter related infection * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Kidney infection * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Sepsis * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Skin infection * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Investigations     
Alanine aminotransferase increased * 1  0/33 (0.00%)  0 2/31 (6.45%)  2
Alkaline phosphatase increased * 1  1/33 (3.03%)  1 2/31 (6.45%)  2
Aspartate aminotransferase increased * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Hyperbilirubinemia * 1  1/33 (3.03%)  1 3/31 (9.68%)  3
INR increased * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Neutrophil count decreased * 1  0/33 (0.00%)  0 8/31 (25.81%)  8
Metabolism and nutrition disorders     
Anorexia * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Dehydration * 1  4/33 (12.12%)  4 1/31 (3.23%)  1
Hyperkalemia * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Hypoalbuminemia * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Iron increased * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/33 (6.06%)  2 0/31 (0.00%)  0
Nervous system disorders     
Ischemia cerebrovascular * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Peripheral sensory neuropathy * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/33 (3.03%)  1 1/31 (3.23%)  1
Vascular disorders     
Hypotension * 1  2/33 (6.06%)  2 0/31 (0.00%)  0
Thrombosis * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/33 (100.00%)      31/31 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin decreased * 1  17/33 (51.52%)  23 18/31 (58.06%)  29
Hemolysis * 1  0/33 (0.00%)  0 1/31 (3.23%)  2
Cardiac disorders     
Atrial fibrillation * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Eye disorders     
Flashing vision * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Vision blurred * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Watering eyes * 1  1/33 (3.03%)  2 0/31 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension * 1  2/33 (6.06%)  2 3/31 (9.68%)  4
Abdominal pain * 1  14/33 (42.42%)  21 10/31 (32.26%)  12
Ascites * 1  1/33 (3.03%)  1 1/31 (3.23%)  1
Constipation * 1  10/33 (30.30%)  13 10/31 (32.26%)  14
Diarrhea * 1  8/33 (24.24%)  10 8/31 (25.81%)  10
Dry mouth * 1  2/33 (6.06%)  3 0/31 (0.00%)  0
Dysphagia * 1  0/33 (0.00%)  0 2/31 (6.45%)  2
Flatulence * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Gastrointestinal disorder * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Mucositis oral * 1  3/33 (9.09%)  3 0/31 (0.00%)  0
Nausea * 1  7/33 (21.21%)  12 10/31 (32.26%)  13
Small intestinal obstruction * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Vomiting * 1  5/33 (15.15%)  7 8/31 (25.81%)  8
General disorders     
Disease progression * 1  29/33 (87.88%)  29 24/31 (77.42%)  24
Edema limbs * 1  4/33 (12.12%)  5 4/31 (12.90%)  6
Fatigue * 1  20/33 (60.61%)  40 19/31 (61.29%)  29
Fever * 1  2/33 (6.06%)  3 5/31 (16.13%)  5
Localized edema * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Pain * 1  1/33 (3.03%)  1 1/31 (3.23%)  1
Hepatobiliary disorders     
Hepatic failure * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Infections and infestations     
Pneumonia * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Skin infection * 1  1/33 (3.03%)  2 1/31 (3.23%)  1
Soft tissue infection * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Urinary tract infection * 1  2/33 (6.06%)  3 2/31 (6.45%)  2
Investigations     
Activated partial thromboplastin time prolonged * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Alanine aminotransferase increased * 1  8/33 (24.24%)  10 3/31 (9.68%)  4
Alkaline phosphatase increased * 1  13/33 (39.39%)  24 16/31 (51.61%)  28
Aspartate aminotransferase increased * 1  13/33 (39.39%)  19 13/31 (41.94%)  23
Cardiac troponin T increased * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Creatinine increased * 1  2/33 (6.06%)  2 1/31 (3.23%)  1
Hyperbilirubinemia * 1  8/33 (24.24%)  10 4/31 (12.90%)  4
Laboratory test abnormal * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Leukopenia * 1  6/33 (18.18%)  8 13/31 (41.94%)  17
Lymphopenia * 1  0/33 (0.00%)  0 2/31 (6.45%)  2
Neutrophil count decreased * 1  9/33 (27.27%)  12 15/31 (48.39%)  19
Platelet count decreased * 1  2/33 (6.06%)  3 7/31 (22.58%)  9
Weight loss * 1  0/33 (0.00%)  0 2/31 (6.45%)  2
Metabolism and nutrition disorders     
Anorexia * 1  13/33 (39.39%)  22 11/31 (35.48%)  16
Dehydration * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Hypercalcemia * 1  2/33 (6.06%)  2 0/31 (0.00%)  0
Hyperglycemia * 1  11/33 (33.33%)  15 10/31 (32.26%)  18
Hyperkalemia * 1  2/33 (6.06%)  2 1/31 (3.23%)  1
Hypernatremia * 1  2/33 (6.06%)  2 2/31 (6.45%)  2
Hypoalbuminemia * 1  9/33 (27.27%)  12 10/31 (32.26%)  15
Hypocalcemia * 1  3/33 (9.09%)  3 7/31 (22.58%)  9
Hypoglycemia * 1  2/33 (6.06%)  2 1/31 (3.23%)  1
Hypokalemia * 1  1/33 (3.03%)  1 2/31 (6.45%)  3
Hypomagnesemia * 1  1/33 (3.03%)  1 1/31 (3.23%)  1
Hyponatremia * 1  5/33 (15.15%)  11 7/31 (22.58%)  10
Hypophosphatemia * 1  3/33 (9.09%)  4 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Back pain * 1  1/33 (3.03%)  1 3/31 (9.68%)  3
Bone pain * 1  3/33 (9.09%)  3 3/31 (9.68%)  3
Joint pain * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Muscle weakness * 1  4/33 (12.12%)  6 1/31 (3.23%)  1
Muscle weakness upper limb * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Myalgia * 1  2/33 (6.06%)  2 4/31 (12.90%)  6
Pain in extremity * 1  1/33 (3.03%)  1 1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplasia * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Tumor pain * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders     
Dizziness * 1  3/33 (9.09%)  4 4/31 (12.90%)  4
Headache * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Neuralgia * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Peripheral motor neuropathy * 1  0/33 (0.00%)  0 1/31 (3.23%)  2
Peripheral sensory neuropathy * 1  7/33 (21.21%)  9 9/31 (29.03%)  16
Psychiatric disorders     
Agitation * 1  0/33 (0.00%)  0 1/31 (3.23%)  3
Anxiety * 1  4/33 (12.12%)  5 5/31 (16.13%)  8
Confusion * 1  1/33 (3.03%)  2 0/31 (0.00%)  0
Depression * 1  3/33 (9.09%)  4 5/31 (16.13%)  6
Euphoria * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Insomnia * 1  5/33 (15.15%)  5 9/31 (29.03%)  10
Personality change * 1  1/33 (3.03%)  2 0/31 (0.00%)  0
Renal and urinary disorders     
Bladder hemorrhage * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Proteinuria * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Urine discoloration * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Reproductive system and breast disorders     
Pelvic pain * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/33 (6.06%)  3 3/31 (9.68%)  4
Dyspnea * 1  2/33 (6.06%)  3 3/31 (9.68%)  4
Hiccough * 1  1/33 (3.03%)  2 0/31 (0.00%)  0
Pleural effusion * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/33 (3.03%)  1 1/31 (3.23%)  1
Dry skin * 1  4/33 (12.12%)  7 5/31 (16.13%)  9
Nail disorder * 1  2/33 (6.06%)  4 1/31 (3.23%)  1
Pain of skin * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Pruritus * 1  1/33 (3.03%)  2 2/31 (6.45%)  2
Rash desquamating * 1  5/33 (15.15%)  8 2/31 (6.45%)  2
Skin hyperpigmentation * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Skin ulceration * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Sweating * 1  0/33 (0.00%)  0 1/31 (3.23%)  1
Vascular disorders     
Flushing * 1  2/33 (6.06%)  2 2/31 (6.45%)  2
Hot flashes * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
Hypertension * 1  1/33 (3.03%)  1 2/31 (6.45%)  2
Hypotension * 1  1/33 (3.03%)  1 0/31 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
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: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103311     History of Changes
Other Study ID Numbers: NCI-2012-02834
NCI-2012-02834 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHII-51 ( Other Identifier: City of Hope )
6800 ( Other Identifier: CTEP )
First Submitted: February 7, 2005
First Posted: February 8, 2005
Results First Submitted: February 13, 2015
Results First Posted: March 2, 2015
Last Update Posted: March 2, 2015