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Trial record 20 of 1309 for:    survival | Neuroendocrine Tumors

Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00398320
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : December 10, 2013
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Pamela L. Kunz, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroendocrine Tumors
Interventions Drug: Capecitabine
Drug: Oxaliplatin
Drug: Bevacizumab
Enrollment 40
Recruitment Details Patients were enrolled at one site in the US over a three-year period.
Pre-assignment Details  
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

Adverse events (AEs) reported are related and grade 3 or higher per CTCAE version 3.

Period Title: Overall Study
Started 40
Completed 34
Not Completed 6
Reason Not Completed
Death             1
Adverse Event             4
Physician Decision             1
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
55
(32 to 76)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
18
  45.0%
Male
22
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title 12-month Progression Free Survival (PFS)
Hide Description Percentage of participants with 12-month progression-free survival (PFS) was assessed. PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first). RECIST criteria (version 1). Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR) defined as ≥ 30% decrease of SLD. Progressive disease (PD) defined as ≥ 20% increase in Sum Longest Diameters (SLD). Stable Disease (SD) defined as being between 20% increase and < 30% decrease in SLD.
Time Frame PFS assessed every 3 months through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description:

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants w/ 12 mo PFS
64.7
2.Primary Outcome
Title Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0
Hide Description Participants were monitored every 3 weeks while on study. Toxicity and attributions were as per CTCAE version 3.0 guidelines. Analysis population below is patient who experienced related Grade 3 or higher AE; denominator is 40 total patients enrolled.
Time Frame 30 days after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description:

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
28
3.Secondary Outcome
Title Response Rates
Hide Description Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as ≥ 30 decrease in the sum of longest diameters of target lesions (SLD). Overall response (OR) = CR + PR.
Time Frame Response rates by RECIST criteria assessed every 3 months while on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description:

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
17.5
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as time from enrollment until death from any cause.
Time Frame Continuous
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description:

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

Overall Number of Participants Analyzed 40
Median (Full Range)
Unit of Measure: months
42.2
(0.6 to 60.8)
5.Secondary Outcome
Title Biochemical Markers
Hide Description [Not Specified]
Time Frame Assessed every 3 weeks while on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
18 of 40 patients had elevated baseline hormone markers, including Chromogranin A, Gastrin, Glucagon, Pancreatic Polypeptide, vasoactive intestinal peptide (VIP), Urine 5HIAA
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description:

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
25 to 49% reduction in 1 or more hormones 6
≥ 50% reduction in 1 or more hormones 12
Time Frame AEs were collected approximately every 3 weeks when patients were seen by treating MD while they were on active treatment.
Adverse Event Reporting Description If a subject experiences more than one of a given AE, the subject is counted only once for that AE.
 
Arm/Group Title Capecitabine / Oxaliplatin / Bevacizumab
Hide Arm/Group Description

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.

All-Cause Mortality
Capecitabine / Oxaliplatin / Bevacizumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine / Oxaliplatin / Bevacizumab
Affected / at Risk (%) # Events
Total   14/40 (35.00%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/40 (2.50%)  1
Gastrointestinal disorders   
Dehydration  1  1/40 (2.50%)  1
Hemorrhage, GI  1  1/40 (2.50%)  1
General disorders   
Death  1  1/40 (2.50%)  1
Weight loss  1  1/40 (2.50%)  1
Anorexia  1  1/40 (2.50%)  1
Fatigue  1  1/40 (2.50%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  3/40 (7.50%)  3
Nervous system disorders   
Syncope  1  1/40 (2.50%)  1
Confusion  1  1/40 (2.50%)  1
Right tongue numbness/deviation  1  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Thrombosis/Embolism  1  2/40 (5.00%)  2
Surgical and medical procedures   
Wound dehiscence  1  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Capecitabine / Oxaliplatin / Bevacizumab
Affected / at Risk (%) # Events
Total   20/40 (50.00%)    
Blood and lymphatic system disorders   
Low hemoglobin  1  2/40 (5.00%) 
Low leukocytes  1  1/40 (2.50%) 
Low neutrophils  1  2/40 (5.00%) 
Cardiac disorders   
Hypertension  1  5/40 (12.50%) 
Ear and labyrinth disorders   
Tinnitus  1  1/40 (2.50%) 
Gastrointestinal disorders   
Dehydration  1  1/40 (2.50%) 
Diarrhea  1  8/40 (20.00%) 
Nausea  1  1/40 (2.50%) 
Bowel obstruction  1  1/40 (2.50%) 
Vomiting  1  1/40 (2.50%) 
Hemorrhage, GI Upper  1  2/40 (5.00%) 
Abdominal pain  1  2/40 (5.00%) 
Metabolism and nutrition disorders   
Elevated Alk Phos  1  1/40 (2.50%) 
Hyperbilirubinemia  1  1/40 (2.50%) 
Proteinuria  1  1/40 (2.50%) 
Hyponatremia  1  1/40 (2.50%) 
Nervous system disorders   
Sensory neuropathy  1  3/40 (7.50%) 
Headache  1  1/40 (2.50%) 
Skin and subcutaneous tissue disorders   
Hand foot skin reaction  1  4/40 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Pamela L Kunz, MD
Organization: Stanford University School of Medicine
Phone: 650-725-8738
Responsible Party: Pamela L. Kunz, Stanford University
ClinicalTrials.gov Identifier: NCT00398320     History of Changes
Other Study ID Numbers: IRB-06233
97273
NET0002 ( Other Identifier: OnCore )
END0002 (formerly) ( Other Identifier: OnCore )
First Submitted: October 31, 2006
First Posted: November 10, 2006
Results First Submitted: October 15, 2013
Results First Posted: December 10, 2013
Last Update Posted: March 1, 2017