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Trial record 100 of 526 for:    "Primary Peritoneal Carcinoma"

Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00408070
Recruitment Status : Terminated (Did not meet accrual goals.)
First Posted : December 6, 2006
Results First Posted : November 16, 2010
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
UConn Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Stage 3 Cancer
Stage 4 Cancer
Interventions Drug: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  40.0%
>=65 years
3
  60.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
62  (11.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Progression Free Survival Rate at 9 Months
Hide Description This Outcome is measuring the number of particpants who have survived.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description:
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Response to Treatment (Clinical/Pathological)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
not assessed; study terminated early
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description:
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Rate of Decline of CA-125
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
not assessed; study terminated early
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description:
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Determine the Degree and Type of Toxicity of This Combined Regimen
Hide Description [Not Specified]
Time Frame weekly
Hide Outcome Measure Data
Hide Analysis Population Description
not assessed; study terminated early
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description:
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
not assessed; study terminated early
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description:
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab Plus Carboplatin and Paclitaxel
Hide Arm/Group Description This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
All-Cause Mortality
Bevacizumab Plus Carboplatin and Paclitaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab Plus Carboplatin and Paclitaxel
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
Infections and infestations   
Febrile Neutropenia   2/5 (40.00%)  2
Nervous system disorders   
Neuropathy - motor   1/5 (20.00%)  1
Renal and urinary disorders   
Renal failure   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab Plus Carboplatin and Paclitaxel
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
hemoglobin decrease   5/5 (100.00%) 
metabolic laboratory - other  [1]  1/5 (20.00%) 
metabolic laboratory - other  [2]  1/5 (20.00%) 
edema - limb   1/5 (20.00%) 
alkaline phosphatase - elevated   1/5 (20.00%) 
creatinine - elevated   2/5 (40.00%) 
ALT (SGPT) - evelated   1/5 (20.00%) 
AST (SGOT) - elevated   1/5 (20.00%) 
lactose dehydrogenase (LDH) - elevated   1/5 (20.00%) 
hemoglobin - elevated   1/5 (20.00%) 
hypoalbuminemia   4/5 (80.00%) 
hyponatremia   5/5 (100.00%) 
hypocalcemia   2/5 (40.00%) 
hypokalemia   1/5 (20.00%) 
hypomagnesemia   4/5 (80.00%) 
leukocytes - decreased   5/5 (100.00%) 
bicarbonate - decreased   2/5 (40.00%) 
lymphopenia   3/5 (60.00%) 
neutrophils/granulocytes - decreased   5/5 (100.00%) 
platelets - decreased   5/5 (100.00%) 
Cardiac disorders   
hypertension   2/5 (40.00%) 
Ear and labyrinth disorders   
hearing alteration   1/5 (20.00%) 
Gastrointestinal disorders   
bloating /abdominal distention   1/5 (20.00%) 
constipation *  2/5 (40.00%) 
dehydration   2/5 (40.00%) 
diarrhea *  3/5 (60.00%) 
dysgeusia *  3/5 (60.00%) 
flatulence *  1/5 (20.00%) 
gastritis   1/5 (20.00%) 
dyspepsia *  3/5 (60.00%) 
mucositis/stomatitis   1/5 (20.00%) 
nausea *  4/5 (80.00%) 
vomiting *  3/5 (60.00%) 
General disorders   
fatigue *  5/5 (100.00%) 
headache *  1/5 (20.00%) 
rigors / chills *  1/5 (20.00%) 
Immune system disorders   
allergic reaction / hypersensitivity   2/5 (40.00%) 
allergic rhinitis   1/5 (20.00%) 
Infections and infestations   
febrile neutorpenia   1/5 (20.00%) 
Infection - skin   1/5 (20.00%) 
infection - urinary tract   2/5 (40.00%) 
infection - upper respiratory   2/5 (40.00%) 
infection - NOS   1/5 (20.00%) 
Metabolism and nutrition disorders   
hyperglycemia   4/5 (80.00%) 
weight loss   1/5 (20.00%) 
Musculoskeletal and connective tissue disorders   
pain - musculoskeletal; joint *  2/5 (40.00%) 
arthritis   1/5 (20.00%) 
pain, bone *  1/5 (20.00%) 
muscle weakness   1/5 (20.00%) 
pain - extremity *  2/5 (40.00%) 
pain - muscle *  1/5 (20.00%) 
seroma   1/5 (20.00%) 
Nervous system disorders   
confusion   1/5 (20.00%) 
dizziness *  1/5 (20.00%) 
memory impairment   1/5 (20.00%) 
neuropathy - sensory   5/5 (100.00%) 
neuropathy - cranial   1/5 (20.00%) 
neuropathy - cranial -CN V   1/5 (20.00%) 
Renal and urinary disorders   
proteinuria   2/5 (40.00%) 
Respiratory, thoracic and mediastinal disorders   
nasal/sinus reactions   3/5 (60.00%) 
pleural effusion   1/5 (20.00%) 
dyspnea   1/5 (20.00%) 
dysarthria   1/5 (20.00%) 
respiratory - other (cold symptoms)   1/5 (20.00%) 
Skin and subcutaneous tissue disorders   
alopecia *  2/5 (40.00%) 
bruising   1/5 (20.00%) 
injection site reaction   1/5 (20.00%) 
nail changes   1/5 (20.00%) 
pruritus *  1/5 (20.00%) 
rash   1/5 (20.00%) 
eczema   1/5 (20.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
elveated BUN/Creatinine
[2]
AST,ALT decreased
This trial ended early after enrolling only 5 of 100 patients. Due to the small enrollment number and incomplete data set, no data analyses were performed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paige Dunion
Organization: UCHC
Phone: 860-679-6571
Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00408070     History of Changes
Other Study ID Numbers: AVF 3696s
IRB 06-337-1
First Submitted: December 5, 2006
First Posted: December 6, 2006
Results First Submitted: October 14, 2010
Results First Posted: November 16, 2010
Last Update Posted: March 8, 2018