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Trial record 7 of 533 for:    "Primary Peritoneal Carcinoma"

A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

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: NCT00671788
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : July 18, 2014
Last Update Posted : April 15, 2016
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 Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Drug: Dasatinib
Other: Laboratory Biomarker Analysis
Enrollment 35
Recruitment Details The study was activated on 6/2/2008 and closed to accrual on 4/12/2010.
Pre-assignment Details  
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Period Title: Overall Study
Started 35
Completed 21 [1]
Not Completed 14
Reason Not Completed
Adverse Event             8
Refused further treatment             3
Ineligible             1
MD Decision             1
Other             1
[1]
Patients treated until disease progression; completed defined as off treatment due to progression.
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
Eligible and treated participants
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
40-49 years 4
50-59 years 9
60-69 years 13
70-79 years 6
80-89 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
34
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Progression-free Survival at 6 Months
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 is 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 Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
20.6
(10.1 to 35.2)
2.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 is 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 any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 8.4)
3.Secondary Outcome
Title Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0
Hide Description [Not Specified]
Time Frame Every cycle during treatment
Outcome Measure Data Not Reported
4.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 is 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 any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
2.1
(1.9 to 3.2)
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Every other cycle up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
18.4 [1] 
(12.9 to NA)
[1]
NA (not applicable): insufficient number of participants with events.
Time Frame Adverse events were queried for and collected every cycle for the duration of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
All-Cause Mortality
Dasatinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dasatinib
Affected / at Risk (%)
Total   18/34 (52.94%) 
Cardiac disorders   
Cardiac General - Other  1/34 (2.94%) 
Gastrointestinal disorders   
Distention  1/34 (2.94%) 
Obstruction, Gi - Small Bowel Nos  5/34 (14.71%) 
Vomiting  1/34 (2.94%) 
Anorexia  1/34 (2.94%) 
Diarrhea  1/34 (2.94%) 
General disorders   
Weight Loss  1/34 (2.94%) 
Pain: Abdominal Pain Nos  3/34 (8.82%) 
Immune system disorders   
Rhinitis  1/34 (2.94%) 
Infections and infestations   
Inf Unknown Anc: Lung (Pneumonia)  1/34 (2.94%) 
Nervous system disorders   
Cns Ischemia  1/34 (2.94%) 
Neuropathy-Motor  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1/34 (2.94%) 
Dyspnea  1/34 (2.94%) 
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%
Dasatinib
Affected / at Risk (%)
Total   33/34 (97.06%) 
Blood and lymphatic system disorders   
Neutrophils  10/34 (29.41%) 
Platelets  6/34 (17.65%) 
Leukocytes  11/34 (32.35%) 
Hemoglobin  31/34 (91.18%) 
Edema: Trunk/Genital  1/34 (2.94%) 
Edema: Limb  2/34 (5.88%) 
Edema: Head And Neck  3/34 (8.82%) 
Cardiac disorders   
Prolonged Qtc Interval  1/34 (2.94%) 
S/N Arrhythmia: Atrial Fibrillation  1/34 (2.94%) 
Pericardial Effusion  2/34 (5.88%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  1/34 (2.94%) 
Hearing (Without Monitoring Program)  1/34 (2.94%) 
Endocrine disorders   
Hot Flashes  2/34 (5.88%) 
Eye disorders   
Blurred Vision  1/34 (2.94%) 
Gastrointestinal disorders   
Heartburn  6/34 (17.65%) 
Ascites  3/34 (8.82%) 
Ileus  1/34 (2.94%) 
Distention  3/34 (8.82%) 
Taste Alteration  4/34 (11.76%) 
Obstruction, Gi - Small Bowel Nos  2/34 (5.88%) 
Mucositis (Clinical Exam) - Oral Cavity  1/34 (2.94%) 
Vomiting  12/34 (35.29%) 
Anorexia  13/34 (38.24%) 
Dehydration  1/34 (2.94%) 
Constipation  12/34 (35.29%) 
Nausea  16/34 (47.06%) 
Diarrhea  10/34 (29.41%) 
General disorders   
Sweating  2/34 (5.88%) 
Weight Gain  1/34 (2.94%) 
Fever  3/34 (8.82%) 
Weight Loss  3/34 (8.82%) 
Rigors/Chills  2/34 (5.88%) 
Fatigue  20/34 (58.82%) 
Insomnia  3/34 (8.82%) 
Pain: Pelvis  1/34 (2.94%) 
Pain: Head/Headache  7/34 (20.59%) 
Pain: Extremity-Limb  1/34 (2.94%) 
Pain: Joint  4/34 (11.76%) 
Pain: Abdominal Pain Nos  12/34 (35.29%) 
Pain: Muscle  1/34 (2.94%) 
Immune system disorders   
Allergic Reaction/Hypersensitivity  1/34 (2.94%) 
Rhinitis  3/34 (8.82%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)  1/34 (2.94%) 
Inf Unknown Anc: Upper Airway Nos  1/34 (2.94%) 
Metabolism and nutrition disorders   
Ast  5/34 (14.71%) 
Metabolic/Laboratory - Other  1/34 (2.94%) 
Creatinine  4/34 (11.76%) 
Hypoalbuminemia  2/34 (5.88%) 
Alt  3/34 (8.82%) 
Alkaline Phosphatase  3/34 (8.82%) 
Hyponatremia  1/34 (2.94%) 
Hypernatremia  3/34 (8.82%) 
Hypocalcemia  5/34 (14.71%) 
Hyperglycemia  4/34 (11.76%) 
Hypokalemia  6/34 (17.65%) 
Hypercalcemia  3/34 (8.82%) 
Hypomagnesemia  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1/34 (2.94%) 
Muscle Weakness - Whole Body/Generalized  1/34 (2.94%) 
Nervous system disorders   
Mood Alteration - Depression  2/34 (5.88%) 
Mood Alteration - Anxiety  1/34 (2.94%) 
Confusion  1/34 (2.94%) 
Dizziness  4/34 (11.76%) 
Neuropathy-Sensory  4/34 (11.76%) 
Renal and urinary disorders   
Urinary Retention  1/34 (2.94%) 
Urinary Frequency  1/34 (2.94%) 
Reproductive system and breast disorders   
Vaginal Discharge  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Cough  6/34 (17.65%) 
Pleural Effusion  5/34 (14.71%) 
Dyspnea  12/34 (35.29%) 
Skin and subcutaneous tissue disorders   
Hair Loss/Alopecia (Scalp Or Body)  3/34 (8.82%) 
Rash  4/34 (11.76%) 
Dry Skin  1/34 (2.94%) 
Pruritus  1/34 (2.94%) 
Flushing  2/34 (5.88%) 
Vascular disorders   
Ptt  1/34 (2.94%) 
Hemorrhage, Gu - Vagina  2/34 (5.88%) 
Hemorrhage, Gi - Rectum  1/34 (2.94%) 
Hemorrhage, Cns  1/34 (2.94%) 
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: Jessalyn Reboy
Organization: Gynecologic Oncology Group Statistical and Data Center
Phone: 716-845-7738
EMail: reboyj@nrgoncology.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00671788     History of Changes
Other Study ID Numbers: GOG-0170M
NCI-2011-03824 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000594930
GOG-0170M ( Other Identifier: Gynecologic Oncology Group )
GOG-0170M ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: May 2, 2008
First Posted: May 5, 2008
Results First Submitted: January 31, 2014
Results First Posted: July 18, 2014
Last Update Posted: April 15, 2016