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Sorafenib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic 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: NCT00114244
Recruitment Status : Completed
First Posted : June 14, 2005
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stage IV Pancreatic Cancer
Interventions Drug: sorafenib tosylate
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Hide Arm/Group Description

Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.

sorafenib tosylate: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.

sorafenib tosylate: Given PO

gemcitabine hydrochloride: Given IV

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 15 37
Completed 13 30
Not Completed 2 7
Reason Not Completed
Adverse Event             2             5
Withdrawal by Subject             0             2
Arm/Group Title Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) Total
Hide Arm/Group Description

Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.

sorafenib tosylate: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.

sorafenib tosylate: Given PO

gemcitabine hydrochloride: Given IV

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 15 37 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 37 participants 52 participants
66
(55 to 82)
65
(43 to 83)
65
(43 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 37 participants 52 participants
Female
6
  40.0%
15
  40.5%
21
  40.4%
Male
9
  60.0%
22
  59.5%
31
  59.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 37 participants 52 participants
15 37 52
1.Primary Outcome
Title Objective Response (OR = 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 CT scan, MRI, X-ray: 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 Every 6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Hide Arm/Group Description:

Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.

sorafenib tosylate: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.

sorafenib tosylate: Given PO

gemcitabine hydrochloride: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 15 37
Measure Type: Number
Unit of Measure: participants
0 1
2.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier by arm.
Time Frame From first day of treatment to time of death due to any cause, assessed up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Hide Arm/Group Description:

Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.

sorafenib tosylate: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.

sorafenib tosylate: Given PO

gemcitabine hydrochloride: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 15 37
Median (95% Confidence Interval)
Unit of Measure: Months
4.3
(3.3 to 8.3)
6.5
(5.5 to 8.0)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood’s standard errors will be summarized by arm.
Time Frame From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Hide Arm/Group Description:

Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.

sorafenib tosylate: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.

sorafenib tosylate: Given PO

gemcitabine hydrochloride: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 15 37
Median (95% Confidence Interval)
Unit of Measure: Months
2.3
(1.2 to 5.7)
2.9
(2.1 to 4.3)
Time Frame Adverse Events occured over a 36 month period.
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 (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Hide Arm/Group Description

Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.

sorafenib tosylate: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15.

sorafenib tosylate: Given PO

gemcitabine hydrochloride: Given IV

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/15 (53.33%)      15/37 (40.54%)    
Cardiac disorders     
Sinus tachycardia * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  1/15 (6.67%)  2 2/37 (5.41%)  2
Cheilitis * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Constipation * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Diarrhea * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Duodenal hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Esophagitis * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Gastritis * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Gastrointestinal disorder * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Intra-abdominal hemorrhage * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Nausea * 1  1/15 (6.67%)  2 2/37 (5.41%)  2
Obstruction gastric * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Small intestinal obstruction * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Upper gastrointestinal hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Vomiting * 1  1/15 (6.67%)  1 2/37 (5.41%)  2
General disorders     
Death * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Disease progression * 1  2/15 (13.33%)  2 3/37 (8.11%)  3
Fatigue * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Pain * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Hepatobiliary disorders     
Gallbladder obstruction * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Infections and infestations     
Catheter related infection * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Skin infection * 1  1/15 (6.67%)  1 1/37 (2.70%)  1
Injury, poisoning and procedural complications     
Vascular access complication * 1  0/15 (0.00%)  0 3/37 (8.11%)  3
Investigations     
Alkaline phosphatase increased * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hyperbilirubinemia * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Metabolism and nutrition disorders     
Dehydration * 1  1/15 (6.67%)  1 2/37 (5.41%)  2
Hypocalcemia * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hyponatremia * 1  0/15 (0.00%)  0 2/37 (5.41%)  2
Nervous system disorders     
Ischemia cerebrovascular * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Vascular disorders     
Thrombosis * 1  4/15 (26.67%)  4 4/37 (10.81%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Sorafenib Tosylate) Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      37/37 (100.00%)    
Blood and lymphatic system disorders     
Blood disorder * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hemoglobin decreased * 1  4/15 (26.67%)  13 17/37 (45.95%)  49
Thrombotic microangiopathy * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Cardiac disorders     
Sinus bradycardia * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Sinus tachycardia * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Ventricular flutter * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Ear and labyrinth disorders     
Ear disorder * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Ear pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Tinnitus * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Eye disorders     
Vision blurred * 1  0/15 (0.00%)  0 2/37 (5.41%)  4
Gastrointestinal disorders     
Abdominal distension * 1  0/15 (0.00%)  0 3/37 (8.11%)  3
Abdominal pain * 1  10/15 (66.67%)  17 21/37 (56.76%)  45
Ascites * 2  0/15 (0.00%)  0 2/37 (5.41%)  3
Constipation * 1  7/15 (46.67%)  9 14/37 (37.84%)  32
Diarrhea * 1  5/15 (33.33%)  18 16/37 (43.24%)  36
Dyspepsia * 1  0/15 (0.00%)  0 3/37 (8.11%)  4
Dysphagia * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Ear, nose and throat examination abnormal * 1  0/15 (0.00%)  0 5/37 (13.51%)  6
Esophageal mucositis * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Esophagitis * 1  0/15 (0.00%)  0 2/37 (5.41%)  3
Flatulence * 1  0/15 (0.00%)  0 4/37 (10.81%)  6
Gastritis * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Gastro-intestinal fistula * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hemorrhoids * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Intra-abdominal hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Lower gastrointestinal hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Mucositis oral * 1  0/15 (0.00%)  0 3/37 (8.11%)  5
Nausea * 1  8/15 (53.33%)  13 14/37 (37.84%)  23
Oral pain * 1  1/15 (6.67%)  2 0/37 (0.00%)  0
Rectal hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Small intestinal obstruction * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Stomach pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Vomiting * 1  5/15 (33.33%)  8 8/37 (21.62%)  10
General disorders     
Chills * 1  0/15 (0.00%)  0 7/37 (18.92%)  7
Death * 1  1/15 (6.67%)  1 7/37 (18.92%)  7
Disease progression * 1  11/15 (73.33%)  11 18/37 (48.65%)  18
Edema limbs * 1  1/15 (6.67%)  1 4/37 (10.81%)  8
Fatigue * 1  10/15 (66.67%)  33 27/37 (72.97%)  64
Fever * 1  1/15 (6.67%)  1 4/37 (10.81%)  4
Flu-like symptoms * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
General symptom * 1  1/15 (6.67%)  2 1/37 (2.70%)  1
Pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Pericardial pain * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Sudden death * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hepatobiliary disorders     
Hepatic failure * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Immune system disorders     
Hypersensitivity * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Infections and infestations     
Colitis, infectious (e.g., Clostridium difficile) * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Urinary tract infection * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Wound infection * 1  0/15 (0.00%)  0 1/37 (2.70%)  3
Injury, poisoning and procedural complications     
Wound dehiscence * 1  0/15 (0.00%)  0 3/37 (8.11%)  4
Investigations     
Alanine aminotransferase increased * 1  2/15 (13.33%)  3 19/37 (51.35%)  40
Alkaline phosphatase increased * 1  5/15 (33.33%)  14 22/37 (59.46%)  41
Aspartate aminotransferase increased * 1  2/15 (13.33%)  4 18/37 (48.65%)  43
Creatinine increased * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Hyperbilirubinemia * 1  2/15 (13.33%)  3 6/37 (16.22%)  7
Leukocyte count decreased * 2  0/15 (0.00%)  0 3/37 (8.11%)  3
Leukopenia * 1  1/15 (6.67%)  6 9/37 (24.32%)  18
Lymphocyte count decreased * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Lymphopenia * 1  1/15 (6.67%)  3 7/37 (18.92%)  13
Neutrophil count decreased * 1  2/15 (13.33%)  6 17/37 (45.95%)  29
Platelet count decreased * 1  3/15 (20.00%)  10 21/37 (56.76%)  54
Serum cholesterol increased * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Weight loss * 1  3/15 (20.00%)  5 10/37 (27.03%)  15
Metabolism and nutrition disorders     
Anorexia * 1  7/15 (46.67%)  17 21/37 (56.76%)  38
Blood bicarbonate decreased * 1  0/15 (0.00%)  0 3/37 (8.11%)  3
Blood glucose increased * 2  0/15 (0.00%)  0 3/37 (8.11%)  3
Dehydration * 1  0/15 (0.00%)  0 3/37 (8.11%)  4
Glucose intolerance * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Hypercalcemia * 1  0/15 (0.00%)  0 3/37 (8.11%)  3
Hyperglycemia * 1  2/15 (13.33%)  10 14/37 (37.84%)  29
Hyperkalemia * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Hypermagnesemia * 1  0/15 (0.00%)  0 2/37 (5.41%)  2
Hypernatremia * 1  1/15 (6.67%)  1 2/37 (5.41%)  2
Hypoalbuminemia * 1  1/15 (6.67%)  6 8/37 (21.62%)  19
Hypocalcemia * 1  1/15 (6.67%)  5 9/37 (24.32%)  16
Hypoglycemia * 1  1/15 (6.67%)  2 3/37 (8.11%)  3
Hypokalemia * 1  2/15 (13.33%)  2 8/37 (21.62%)  16
Hypomagnesemia * 1  0/15 (0.00%)  0 6/37 (16.22%)  8
Hyponatremia * 1  0/15 (0.00%)  0 5/37 (13.51%)  7
Hypophosphatemia * 1  1/15 (6.67%)  1 3/37 (8.11%)  7
Iron increased * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Serum albumin decreased * 2  0/15 (0.00%)  0 2/37 (5.41%)  2
Serum calcium decreased * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Serum calcium increased * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Serum glucose decreased * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Serum phosphate decreased * 2  0/15 (0.00%)  0 2/37 (5.41%)  2
Serum potassium decreased * 2  0/15 (0.00%)  0 2/37 (5.41%)  2
Serum triglycerides increased * 2  0/15 (0.00%)  0 1/37 (2.70%)  2
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/15 (20.00%)  4 4/37 (10.81%)  5
Bone pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Joint disorder * 1  0/15 (0.00%)  0 2/37 (5.41%)  2
Joint effusion * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Joint pain * 1  0/15 (0.00%)  0 2/37 (5.41%)  2
Muscle weakness * 1  2/15 (13.33%)  3 0/37 (0.00%)  0
Muscle weakness lower limb * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Myalgia * 1  1/15 (6.67%)  1 3/37 (8.11%)  3
Pain in extremity * 1  0/15 (0.00%)  0 3/37 (8.11%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Nervous system disorders     
Depressed level of consciousness * 1  2/15 (13.33%)  2 0/37 (0.00%)  0
Dizziness * 1  0/15 (0.00%)  0 4/37 (10.81%)  6
Headache * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Mental status changes * 1  0/15 (0.00%)  0 1/37 (2.70%)  4
Neuralgia * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Peripheral motor neuropathy * 1  0/15 (0.00%)  0 5/37 (13.51%)  6
Peripheral sensory neuropathy * 1  1/15 (6.67%)  1 2/37 (5.41%)  11
Speech disorder * 1  1/15 (6.67%)  1 0/37 (0.00%)  0
Taste alteration * 1  0/15 (0.00%)  0 2/37 (5.41%)  4
Psychiatric disorders     
Anxiety * 1  0/15 (0.00%)  0 1/37 (2.70%)  2
Insomnia * 1  1/15 (6.67%)  1 7/37 (18.92%)  8
Personality change * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Renal and urinary disorders     
Bladder hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hemorrhage urinary tract * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Proteinuria * 1  1/15 (6.67%)  1 3/37 (8.11%)  4
Urine discoloration * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Reproductive system and breast disorders     
Breast pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Testicular pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Vaginal hemorrhage * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/15 (6.67%)  1 2/37 (5.41%)  4
Dyspnea * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hemorrhage nasal * 1  0/15 (0.00%)  0 2/37 (5.41%)  3
Hiccough * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Pharyngolaryngeal pain * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Pneumonitis * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Respiratory disorder * 1  0/15 (0.00%)  0 2/37 (5.41%)  2
Voice alteration * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Skin and subcutaneous tissue disorders     
Acne * 1  2/15 (13.33%)  2 2/37 (5.41%)  3
Alopecia * 1  1/15 (6.67%)  2 10/37 (27.03%)  31
Dry skin * 1  0/15 (0.00%)  0 1/37 (2.70%)  3
Erythema multiforme * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Hand-and-foot syndrome * 1  2/15 (13.33%)  2 5/37 (13.51%)  9
Pruritus * 1  1/15 (6.67%)  1 1/37 (2.70%)  1
Rash desquamating * 1  3/15 (20.00%)  3 9/37 (24.32%)  10
Skin disorder * 1  0/15 (0.00%)  0 1/37 (2.70%)  1
Sweating * 1  2/15 (13.33%)  4 2/37 (5.41%)  3
Vascular disorders     
Hypertension * 1  0/15 (0.00%)  0 2/37 (5.41%)  2
Phlebitis * 2  0/15 (0.00%)  0 1/37 (2.70%)  1
Phlebitis superficial * 1  1/15 (6.67%)  1 1/37 (2.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
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
Layout table for Results Point of Contact information
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00114244     History of Changes
Other Study ID Numbers: NCI-2012-02835
NCI-2012-02835 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHII-50 ( Other Identifier: City of Hope )
6576 ( Other Identifier: CTEP )
N01CM62209 ( U.S. NIH Grant/Contract )
First Submitted: June 13, 2005
First Posted: June 14, 2005
Results First Submitted: January 6, 2015
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015