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Trial record 25 of 533 for:    "Primary Peritoneal Carcinoma"

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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: NCT00499252
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : December 13, 2013
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Intervention Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Enrollment 51
Recruitment Details The study was activated on 6/4/2007 and closed to accrual on 1/29/2009.
Pre-assignment Details  
Arm/Group Title Abraxane®
Hide Arm/Group Description Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Period Title: Overall Study
Started 51
Completed 39 [1]
Not Completed 12
Reason Not Completed
Adverse Event             3
Refused further treatment             2
Ineligible             4
<no further label>             3
[1]
Patients treated until disease progression; completed defined as off treatment due to progression.
Arm/Group Title Abraxane®
Hide Arm/Group Description Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
20-29 years 0
30-39 years 1
40-49 years 8
50-59 years 16
60-69 years 15
70-79 years 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
47
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Tumor Response
Hide Description

Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Time Frame every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Abraxane®
Hide Arm/Group Description:
Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
23.4
(12.3 to 38.0)
2.Primary Outcome
Title Frequency and Severity of Observed Adverse Effects
Hide Description [Not Specified]
Time Frame Every cycle during treatment and up to 5 years after completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Treated and Eligible patients
Arm/Group Title Grade 0 Grade 1 (CTCAE v 3.0) Grade 2 (CTCAE v 3.0) Grade 3 (CTCAE v 3.0)
Hide Arm/Group Description:
Number of patients who did not experience the specified AE.
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Overall Number of Participants Analyzed 47 47 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
20
  42.6%
15
  31.9%
11
  23.4%
1
   2.1%
Thrombocytopenia
43
  91.5%
4
   8.5%
0
   0.0%
0
   0.0%
Neutropenia
30
  63.8%
5
  10.6%
6
  12.8%
6
  12.8%
Anemia
5
  10.6%
19
  40.4%
20
  42.6%
3
   6.4%
Cardiac
45
  95.7%
2
   4.3%
0
   0.0%
0
   0.0%
Constitutional
12
  25.5%
20
  42.6%
15
  31.9%
0
   0.0%
Dermatologic
28
  59.6%
10
  21.3%
9
  19.1%
0
   0.0%
Gastrointestinal
18
  38.3%
19
  40.4%
8
  17.0%
2
   4.3%
Hemorrhage
45
  95.7%
1
   2.1%
1
   2.1%
0
   0.0%
Lymphatics
41
  87.2%
6
  12.8%
0
   0.0%
0
   0.0%
Metabolic
35
  74.5%
8
  17.0%
2
   4.3%
2
   4.3%
Musculoskeletal
44
  93.6%
2
   4.3%
1
   2.1%
0
   0.0%
Neurosensory
27
  57.4%
14
  29.8%
5
  10.6%
1
   2.1%
Other neurological
42
  89.4%
4
   8.5%
1
   2.1%
0
   0.0%
Ocular/Visual
45
  95.7%
1
   2.1%
1
   2.1%
0
   0.0%
Pain
32
  68.1%
10
  21.3%
3
   6.4%
2
   4.3%
Pulmonary
40
  85.1%
3
   6.4%
4
   8.5%
0
   0.0%
3.Secondary Outcome
Title Progression-free Survival
Hide Description

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 (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Time Frame from study entry until disease progression, death or date of last contact.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Abraxane®
Hide Arm/Group Description:
Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
4.5
(2.2 to 6.7)
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame from entry into the study to death or the date of last contact.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Abraxane®
Hide Arm/Group Description:
Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
17.4
(13.2 to 20.8)
Time Frame every cycle
Adverse Event Reporting Description "Number of participants at risk" total includes eligible and treated patients.
 
Arm/Group Title Abraxane®
Hide Arm/Group Description Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
All-Cause Mortality
Abraxane®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abraxane®
Affected / at Risk (%)
Total   11/47 (23.40%) 
Gastrointestinal disorders   
Ileus  2/47 (4.26%) 
Obstruction, Gi - Small Bowel Nos  4/47 (8.51%) 
Vomiting  1/47 (2.13%) 
Dehydration  1/47 (2.13%) 
General disorders   
Pain: Extremity-Limb  1/47 (2.13%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)  1/47 (2.13%) 
Metabolism and nutrition disorders   
Hypercalcemia  1/47 (2.13%) 
Renal and urinary disorders   
Obstruction, Gu - Ureter  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1/47 (2.13%) 
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 0%
Abraxane®
Affected / at Risk (%)
Total   47/47 (100.00%) 
Blood and lymphatic system disorders   
Neutrophils  17/47 (36.17%) 
Platelets  4/47 (8.51%) 
Leukocytes  28/47 (59.57%) 
Hemoglobin  42/47 (89.36%) 
Lymphedema-Related Fibrosis  1/47 (2.13%) 
Edema: Trunk/Genital  2/47 (4.26%) 
Edema: Limb  8/47 (17.02%) 
Cardiac disorders   
Palpitations  1/47 (2.13%) 
Ventricular Arrhythmia - Tachycardia  1/47 (2.13%) 
Hypertension  1/47 (2.13%) 
Cardiac General - Other  1/47 (2.13%) 
Hypotension  1/47 (2.13%) 
Ear and labyrinth disorders   
Tinnitus  1/47 (2.13%) 
Endocrine disorders   
Hot Flashes  3/47 (6.38%) 
Eye disorders   
Blurred Vision  3/47 (6.38%) 
Gastrointestinal disorders   
Fistula, Gi - Small Bowel Nos  1/47 (2.13%) 
Esophagitis  1/47 (2.13%) 
Heartburn  3/47 (6.38%) 
Dental: Teeth  1/47 (2.13%) 
Ascites  1/47 (2.13%) 
Ileus  1/47 (2.13%) 
Dysphagia  1/47 (2.13%) 
Distention  3/47 (6.38%) 
Taste Alteration  2/47 (4.26%) 
Mucositis (Functional/Sympt) - Oral Cavity  2/47 (4.26%) 
Obstruction, Gi - Small Bowel Nos  3/47 (6.38%) 
Mucositis (Clinical Exam) - Oral Cavity  1/47 (2.13%) 
Vomiting  14/47 (29.79%) 
Anorexia  7/47 (14.89%) 
Dehydration  2/47 (4.26%) 
Constipation  12/47 (25.53%) 
Nausea  21/47 (44.68%) 
Diarrhea  12/47 (25.53%) 
General disorders   
Sweating  1/47 (2.13%) 
Weight Gain  5/47 (10.64%) 
Fever  2/47 (4.26%) 
Weight Loss  2/47 (4.26%) 
Rigors/Chills  1/47 (2.13%) 
Fatigue  33/47 (70.21%) 
Insomnia  2/47 (4.26%) 
Pain - Other  1/47 (2.13%) 
Pain: Pelvis  1/47 (2.13%) 
Pain: Chest /Thorax Nos  2/47 (4.26%) 
Pain: Head/Headache  6/47 (12.77%) 
Pain: Extremity-Limb  4/47 (8.51%) 
Pain: Buttock  1/47 (2.13%) 
Pain: Back  5/47 (10.64%) 
Pain: Joint  7/47 (14.89%) 
Pain: Bone  1/47 (2.13%) 
Pain: Pain Nos  1/47 (2.13%) 
Pain: Stomach  1/47 (2.13%) 
Pain: Rectum  1/47 (2.13%) 
Pain: Abdominal Pain Nos  14/47 (29.79%) 
Pain: Tumor  1/47 (2.13%) 
Pain: Muscle  1/47 (2.13%) 
Pain: Neuralgia  1/47 (2.13%) 
Immune system disorders   
Rhinitis  1/47 (2.13%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos  1/47 (2.13%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums  1/47 (2.13%) 
Inf Unknown Anc: Sinus  1/47 (2.13%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos  4/47 (8.51%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus  1/47 (2.13%) 
Inf Unknown Anc: Upper Airway Nos  1/47 (2.13%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus  2/47 (4.26%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder  2/47 (4.26%) 
Metabolism and nutrition disorders   
Ast  2/47 (4.26%) 
Creatinine  2/47 (4.26%) 
Hypoalbuminemia  2/47 (4.26%) 
Alt  2/47 (4.26%) 
Alkaline Phosphatase  2/47 (4.26%) 
Bilirubin  2/47 (4.26%) 
Hypophosphatemia  2/47 (4.26%) 
Hyponatremia  4/47 (8.51%) 
Hypertriglyceridemia  1/47 (2.13%) 
Hypocalcemia  4/47 (8.51%) 
Hyperkalemia  3/47 (6.38%) 
Hyperglycemia  6/47 (12.77%) 
Hypokalemia  4/47 (8.51%) 
Hypercalcemia  2/47 (4.26%) 
Hypomagnesemia  7/47 (14.89%) 
Musculoskeletal and connective tissue disorders   
Joint-Function  1/47 (2.13%) 
Joint Effusion  1/47 (2.13%) 
Arthritis  2/47 (4.26%) 
Muscle Weakness - Whole Body/Generalized  1/47 (2.13%) 
Muscle Weakness - Extremity-Lower  1/47 (2.13%) 
Nervous system disorders   
Syncope  1/47 (2.13%) 
Mood Alteration - Depression  5/47 (10.64%) 
Mood Alteration - Anxiety  5/47 (10.64%) 
Ataxia  1/47 (2.13%) 
Memory Impairment  1/47 (2.13%) 
Dizziness  3/47 (6.38%) 
Neuropathy-Sensory  24/47 (51.06%) 
Neuropathy-Motor  3/47 (6.38%) 
Renal and urinary disorders   
Cystitis  1/47 (2.13%) 
Incontinence, Urinary  1/47 (2.13%) 
Urinary Frequency  1/47 (2.13%) 
Reproductive system and breast disorders   
Vaginitis  1/47 (2.13%) 
Vaginal Discharge  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary: Other  3/47 (6.38%) 
Nasal/Paranasal Reactions  3/47 (6.38%) 
Pneumothorax  1/47 (2.13%) 
Cough  8/47 (17.02%) 
Pleural Effusion  2/47 (4.26%) 
Dyspnea  11/47 (23.40%) 
Skin and subcutaneous tissue disorders   
Nail Changes  3/47 (6.38%) 
Photosensitivity  1/47 (2.13%) 
Hair Loss/Alopecia (Scalp Or Body)  19/47 (40.43%) 
Bruising  1/47 (2.13%) 
Rash  7/47 (14.89%) 
Dry Skin  1/47 (2.13%) 
Pruritus  1/47 (2.13%) 
Vascular disorders   
Hemorrhage, Gi - Rectum  1/47 (2.13%) 
Hemorrhage/Pulmonary - Nose  3/47 (6.38%) 
Hematoma  1/47 (2.13%) 
Petechiae  1/47 (2.13%) 
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
Layout table for Results Point of Contact information
Name/Title: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00499252     History of Changes
Other Study ID Numbers: GOG-0126R
NCI-2009-00575 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ABRAXIS-ABX-005
CDR0000553208
GOG-0126R ( Other Identifier: Gynecologic Oncology Group )
GOG-0126R ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: October 23, 2013
Results First Posted: December 13, 2013
Last Update Posted: January 11, 2018