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Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00577889
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : November 25, 2013
Last Update Posted : July 25, 2014
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 Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions Drug: gemcitabine hydrochloride
Drug: tanespimycin
Enrollment 21
Recruitment Details A total of 21 patients were accrued from May 30, 2008 to September 2, 2010.
Pre-assignment Details A total of 21 patients were accrued and randomized onto one of 3 parallel arms (Arm I: 9 patients; Arm II: 6 patients; Arm III: 6 patients). One patient from Arm I canceled and was not used in baseline analysis nor endpoint analysis.
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Hide Arm/Group Description Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Period Title: Overall Study
Started 9 6 6
Completed 8 6 6
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy) Total
Hide Arm/Group Description Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Total of all reporting groups
Overall Number of Baseline Participants 8 6 6 20
Hide Baseline Analysis Population Description
One patient in Arm I canceled prior to treatment and was not used in baseline summary.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 6 participants 20 participants
59
(51 to 77)
71
(51 to 81)
67
(55 to 75)
61.5
(51 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 20 participants
Female
3
  37.5%
2
  33.3%
4
  66.7%
9
  45.0%
Male
5
  62.5%
4
  66.7%
2
  33.3%
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 6 participants 20 participants
8 6 6 20
1.Primary Outcome
Title Six Month Survival Rate
Hide Description A patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Hide Arm/Group Description:
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Overall Number of Participants Analyzed 8 6 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
25
(7.5 to 83)
67
(38 to 100)
33
(11 to 100)
2.Secondary Outcome
Title Overall Survival Time
Hide Description Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.
Time Frame Assessed up to 2 years from registration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Hide Arm/Group Description:
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Overall Number of Participants Analyzed 8 6 6
Median (95% Confidence Interval)
Unit of Measure: months
4.8
(2.8 to 6.6)
6.9
(2.4 to 10.7)
4.3
(1.9 to 15.3)
3.Secondary Outcome
Title Time to Disease Progression
Hide Description

The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.

Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).

Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.

Time Frame Time from registration to documentation of disease progression, assessed up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Hide Arm/Group Description:
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Overall Number of Participants Analyzed 8 6 6
Median (95% Confidence Interval)
Unit of Measure: months
2.2
(1.4 to 4)
4.1
(1.4 to 7.9)
2.3
(1.4 to 4.0)
4.Secondary Outcome
Title Confirmed Response Rate
Hide Description

A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.

Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).

Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria.

Time Frame 2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Hide Arm/Group Description:
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
Overall Number of Participants Analyzed 8 6 6
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Hide Arm/Group Description Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9. Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
All-Cause Mortality
Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      2/6 (33.33%)      2/6 (33.33%)    
Gastrointestinal disorders       
Abdominal distension  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Abdominal pain  1  0/8 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Constipation  1  2/8 (25.00%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Diarrhea  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Dyspepsia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Dysphagia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Nausea  1  1/8 (12.50%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2
Small intestinal obstruction  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  1/8 (12.50%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2
General disorders       
Edema limbs  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Fatigue  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations       
Infection  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Investigations       
Lymphocyte count decreased  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Neutrophil count decreased  1  1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Weight loss  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Blood glucose increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Dehydration  1  0/8 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Serum calcium decreased  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Muscle weakness  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders       
Syncope  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pleural effusion  1  1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Pneumothorax  1  1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash desquamating  1  1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders       
Hematoma  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypertension  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Hypotension  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Thrombosis  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Combination Chemotherapy) Arm II (Combination Chemotherapy) Arm III (Combination Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders       
Hemoglobin decreased  1  7/8 (87.50%)  22 4/6 (66.67%)  15 6/6 (100.00%)  16
Gastrointestinal disorders       
Abdominal pain  1  6/8 (75.00%)  13 5/6 (83.33%)  9 5/6 (83.33%)  10
Constipation  1  0/8 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  2
Diarrhea  1  3/8 (37.50%)  6 1/6 (16.67%)  1 2/6 (33.33%)  2
Gastric mucositis  1  1/8 (12.50%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Nausea  1  6/8 (75.00%)  16 4/6 (66.67%)  8 5/6 (83.33%)  8
Vomiting  1  4/8 (50.00%)  8 3/6 (50.00%)  4 3/6 (50.00%)  5
General disorders       
Edema limbs  1  1/8 (12.50%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0
Fatigue  1  7/8 (87.50%)  24 5/6 (83.33%)  16 5/6 (83.33%)  15
General symptom  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Investigations       
Activated partial thromboplastin time prolonged  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Alanine aminotransferase increased  1  4/8 (50.00%)  6 0/6 (0.00%)  0 0/6 (0.00%)  0
Alkaline phosphatase increased  1  4/8 (50.00%)  11 2/6 (33.33%)  9 2/6 (33.33%)  4
Aspartate aminotransferase increased  1  2/8 (25.00%)  2 2/6 (33.33%)  2 0/6 (0.00%)  0
Bilirubin increased  1  0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Leukocyte count decreased  1  4/8 (50.00%)  12 2/6 (33.33%)  3 3/6 (50.00%)  6
Lymphocyte count decreased  1  2/8 (25.00%)  6 0/6 (0.00%)  0 2/6 (33.33%)  2
Neutrophil count decreased  1  4/8 (50.00%)  7 4/6 (66.67%)  8 2/6 (33.33%)  5
Platelet count decreased  1  3/8 (37.50%)  7 2/6 (33.33%)  4 1/6 (16.67%)  1
Weight loss  1  1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  2/8 (25.00%)  5 0/6 (0.00%)  0 2/6 (33.33%)  3
Blood glucose increased  1  3/8 (37.50%)  7 0/6 (0.00%)  0 1/6 (16.67%)  1
Dehydration  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Serum albumin decreased  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Serum calcium decreased  1  2/8 (25.00%)  5 0/6 (0.00%)  0 0/6 (0.00%)  0
Serum calcium increased  1  0/8 (0.00%)  0 2/6 (33.33%)  3 0/6 (0.00%)  0
Serum glucose decreased  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Serum magnesium decreased  1  0/8 (0.00%)  0 1/6 (16.67%)  3 0/6 (0.00%)  0
Serum potassium decreased  1  2/8 (25.00%)  4 1/6 (16.67%)  1 0/6 (0.00%)  0
Serum sodium decreased  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Serum sodium increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  1/8 (12.50%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1
Joint pain  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Headache  1  1/8 (12.50%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Depression  1  1/8 (12.50%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders       
Ureteric obstruction  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Dyspnea  1  1/8 (12.50%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2
Skin and subcutaneous tissue disorders       
Rash desquamating  1  2/8 (25.00%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders       
Hypotension  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Robert McWilliams, M.D.
Organization: Mayo Clinic Cancer Center
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00577889     History of Changes
Obsolete Identifiers: NCT01647022
Other Study ID Numbers: NCI-2009-00156
MC0542
CDR0000445454 ( Registry Identifier: PDQ (Physician Data Query) )
N01CM17104 ( U.S. NIH Grant/Contract )
First Submitted: December 19, 2007
First Posted: December 20, 2007
Results First Submitted: September 20, 2013
Results First Posted: November 25, 2013
Last Update Posted: July 25, 2014