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Trial record 13 of 526 for:    "Primary Peritoneal Carcinoma"

Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00072566
Recruitment Status : Completed
First Posted : November 5, 2003
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Stage IV Ovarian Cancer
Interventions Biological: Bevacizumab
Drug: Cyclophosphamide
Other: Laboratory Biomarker Analysis
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Bevacizumab, Cyclophosphamide)
Hide Arm/Group Description

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

cyclophosphamide: Given PO

Period Title: Overall Study
Started 70
Completed 70
Not Completed 0
Arm/Group Title Treatment (Bevacizumab, Cyclophosphamide)
Hide Arm/Group Description

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

cyclophosphamide: Given PO

Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 70 participants
60
(31 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
70
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants
70
1.Primary Outcome
Title Median Time to Progression
Hide Description Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab, Cyclophosphamide)
Hide Arm/Group Description:

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

cyclophosphamide: Given PO

Overall Number of Participants Analyzed 70
Median (95% Confidence Interval)
Unit of Measure: months
7.2
(5.3 to 8.7)
2.Secondary Outcome
Title Response Rate Based on the RECIST
Hide Description Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab, Cyclophosphamide)
Hide Arm/Group Description:

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

cyclophosphamide: Given PO

Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: percentage of responding patients
24
3.Secondary Outcome
Title Median Overall Survival
Hide Description Calculated using the method of Kaplan-Meier.
Time Frame Time from first day of treatment to time of death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab, Cyclophosphamide)
Hide Arm/Group Description:

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

cyclophosphamide: Given PO

Overall Number of Participants Analyzed 70
Median (95% Confidence Interval)
Unit of Measure: months
16.9
(11.4 to 25.2)
Time Frame [Not Specified]
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Treatment (Bevacizumab, Cyclophosphamide)
Hide Arm/Group Description

Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

cyclophosphamide: Given PO

All-Cause Mortality
Treatment (Bevacizumab, Cyclophosphamide)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Bevacizumab, Cyclophosphamide)
Affected / at Risk (%) # Events
Total   23/70 (32.86%)    
Cardiac disorders   
Sinus tachycardia * 1  1/70 (1.43%)  1
Eye disorders   
Eye pain * 1  1/70 (1.43%)  1
Gastrointestinal disorders   
Abdominal pain * 1  3/70 (4.29%)  3
Cecal obstruction * 1  1/70 (1.43%)  1
Constipation * 1  3/70 (4.29%)  3
Jejunal perforation * 1  1/70 (1.43%)  1
Small intestinal obstruction * 1  5/70 (7.14%)  5
Small intestinal perforation * 1  1/70 (1.43%)  1
General disorders   
Death * 2  2/70 (2.86%)  2
Disease progression * 1  1/70 (1.43%)  1
Fatigue * 1  2/70 (2.86%)  3
Injury, poisoning and procedural complications   
Wound dehiscence * 1  1/70 (1.43%)  1
Investigations   
Alanine aminotransferase increased * 1  2/70 (2.86%)  2
Alkaline phosphatase increased * 1  2/70 (2.86%)  2
Aspartate aminotransferase increased * 1  2/70 (2.86%)  2
Cardiac troponin T increased * 1  1/70 (1.43%)  1
Lymphopenia * 1  1/70 (1.43%)  1
Metabolism and nutrition disorders   
Hyponatremia * 1  1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders   
Arthritis * 1  1/70 (1.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Myelodysplasia * 2  1/70 (1.43%)  1
Nervous system disorders   
Dizziness * 1  2/70 (2.86%)  2
Intracranial hemorrhage * 1  1/70 (1.43%)  1
Ischemia cerebrovascular * 1  2/70 (2.86%)  2
Speech disorder * 1  1/70 (1.43%)  1
Psychiatric disorders   
Confusion * 1  1/70 (1.43%)  1
Renal and urinary disorders   
Proteinuria * 1  1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  2/70 (2.86%)  2
Hypoxia * 1  1/70 (1.43%)  1
Pulmonary hypertension * 1  2/70 (2.86%)  2
Skin and subcutaneous tissue disorders   
Rash desquamating * 1  1/70 (1.43%)  1
Sweating * 1  1/70 (1.43%)  1
Vascular disorders   
Hypertension * 1  1/70 (1.43%)  1
Hypotension * 1  1/70 (1.43%)  1
Thrombosis * 1  2/70 (2.86%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Bevacizumab, Cyclophosphamide)
Affected / at Risk (%) # Events
Total   70/70 (100.00%)    
Blood and lymphatic system disorders   
Blood disorder * 1  1/70 (1.43%)  1
Hemoglobin decreased * 1  32/70 (45.71%)  105
Lymphatic disorder * 1  1/70 (1.43%)  3
Cardiac disorders   
Myocardial ischemia * 1  1/70 (1.43%)  1
Palpitations * 1  2/70 (2.86%)  5
Pericardial effusion * 1  1/70 (1.43%)  16
Sinus tachycardia * 1  4/70 (5.71%)  6
Ear and labyrinth disorders   
Ear pain * 1  2/70 (2.86%)  3
External ear inflammation * 1  1/70 (1.43%)  1
Hearing loss * 1  2/70 (2.86%)  24
Hearing test abnormal * 1  2/70 (2.86%)  18
Tinnitus * 1  5/70 (7.14%)  58
Eye disorders   
Cataract * 1  1/70 (1.43%)  1
Dry eye syndrome * 1  3/70 (4.29%)  4
Eye pain * 1  1/70 (1.43%)  1
Flashing vision * 1  2/70 (2.86%)  11
Vision blurred * 1  5/70 (7.14%)  8
Gastrointestinal disorders   
Abdominal distension * 1  18/70 (25.71%)  47
Abdominal pain * 2  43/70 (61.43%)  142
Ascites * 1  1/70 (1.43%)  1
Colitis * 1  1/70 (1.43%)  1
Colonic perforation * 1  1/70 (1.43%)  1
Constipation * 1  37/70 (52.86%)  129
Diarrhea * 1  27/70 (38.57%)  99
Dry mouth * 1  4/70 (5.71%)  16
Dyspepsia * 1  17/70 (24.29%)  80
Dysphagia * 1  1/70 (1.43%)  1
Ear, nose and throat examination abnormal * 1  2/70 (2.86%)  2
Esophageal pain * 1  2/70 (2.86%)  12
Esophagitis * 1  1/70 (1.43%)  5
Fecal incontinence * 1  1/70 (1.43%)  1
Flatulence * 2  6/70 (8.57%)  12
Gastritis * 1  2/70 (2.86%)  5
Gastrointestinal disorder * 1  7/70 (10.00%)  31
Gastrointestinal pain * 1  3/70 (4.29%)  3
Gingival pain * 1  1/70 (1.43%)  1
Hemorrhoidal hemorrhage * 1  1/70 (1.43%)  1
Hemorrhoids * 1  9/70 (12.86%)  48
Ileus * 1  1/70 (1.43%)  1
Lip pain * 1  1/70 (1.43%)  1
Malabsorption * 1  1/70 (1.43%)  4
Mucositis oral * 1  16/70 (22.86%)  38
Nausea * 1  44/70 (62.86%)  115
Oral hemorrhage * 1  5/70 (7.14%)  21
Oral pain * 1  1/70 (1.43%)  1
Periodontal disease * 1  4/70 (5.71%)  13
Rectal fistula * 1  1/70 (1.43%)  2
Rectal hemorrhage * 1  3/70 (4.29%)  8
Small intestinal obstruction * 1  2/70 (2.86%)  2
Stomach pain * 1  1/70 (1.43%)  3
Tooth disorder * 1  7/70 (10.00%)  26
Toothache * 1  1/70 (1.43%)  2
Vomiting * 1  29/70 (41.43%)  57
General disorders   
Chest pain * 1  5/70 (7.14%)  15
Chills * 1  10/70 (14.29%)  11
Disease progression * 1  41/70 (58.57%)  41
Edema limbs * 1  8/70 (11.43%)  33
Fatigue * 2  63/70 (90.00%)  408
Fever * 1  9/70 (12.86%)  10
Flu-like symptoms * 1  5/70 (7.14%)  6
General symptom * 1  4/70 (5.71%)  5
Injection site reaction * 1  1/70 (1.43%)  1
Localized edema * 1  1/70 (1.43%)  1
Pain * 1  13/70 (18.57%)  36
Immune system disorders   
Hypersensitivity * 1  3/70 (4.29%)  3
Infections and infestations   
Bladder infection * 1  3/70 (4.29%)  21
Conjunctivitis infective * 1  1/70 (1.43%)  2
Infection * 1  6/70 (8.57%)  9
Infectious colitis * 1  1/70 (1.43%)  1
Lip infection * 1  1/70 (1.43%)  1
Opportunistic infection * 1  5/70 (7.14%)  8
Phlebitis infective * 1  2/70 (2.86%)  4
Pneumonia * 1  3/70 (4.29%)  7
Rhinitis infective * 1  2/70 (2.86%)  4
Sinusitis * 1  1/70 (1.43%)  1
Upper respiratory infection * 1  3/70 (4.29%)  5
Urinary tract infection * 1  4/70 (5.71%)  12
Vaginal infection * 1  2/70 (2.86%)  2
Vulvitis * 1  1/70 (1.43%)  2
Injury, poisoning and procedural complications   
Bruising * 1  3/70 (4.29%)  6
Fracture * 1  4/70 (5.71%)  7
Radiation recall reaction (dermatologic) * 1  1/70 (1.43%)  1
Vascular access complication * 1  1/70 (1.43%)  1
Wound dehiscence * 1  2/70 (2.86%)  3
Investigations   
Activated partial thromboplastin time prolonged * 1  14/70 (20.00%)  41
Alanine aminotransferase increased * 1  25/70 (35.71%)  109
Alkaline phosphatase increased * 1  31/70 (44.29%)  97
Amylase increased * 1  3/70 (4.29%)  3
Aspartate aminotransferase increased * 2  29/70 (41.43%)  62
Coagulopathy * 1  1/70 (1.43%)  2
Creatine phosphokinase increased * 1  1/70 (1.43%)  2
Creatinine increased * 1  25/70 (35.71%)  162
Haptoglobin decreased * 2  1/70 (1.43%)  1
Hyperbilirubinemia * 1  3/70 (4.29%)  6
Hypercholesterolemia * 1  1/70 (1.43%)  1
INR increased * 1  5/70 (7.14%)  6
Laboratory test abnormal * 1  1/70 (1.43%)  1
Leukopenia * 1  29/70 (41.43%)  114
Lymphopenia * 1  44/70 (62.86%)  351
Neutrophil count decreased * 1  18/70 (25.71%)  40
Platelet count decreased * 1  10/70 (14.29%)  65
Serum cholesterol increased * 2  1/70 (1.43%)  2
Weight gain * 1  1/70 (1.43%)  2
Weight loss * 1  7/70 (10.00%)  44
Metabolism and nutrition disorders   
Anorexia * 2  28/70 (40.00%)  73
Blood bicarbonate decreased * 1  3/70 (4.29%)  3
Dehydration * 1  1/70 (1.43%)  1
Glucose intolerance * 1  1/70 (1.43%)  19
Hypercalcemia * 1  13/70 (18.57%)  27
Hyperglycemia * 1  19/70 (27.14%)  53
Hyperkalemia * 1  5/70 (7.14%)  16
Hypermagnesemia * 1  3/70 (4.29%)  3
Hypernatremia * 1  7/70 (10.00%)  10
Hypertriglyceridemia * 1  1/70 (1.43%)  2
Hyperuricemia * 1  4/70 (5.71%)  10
Hypoalbuminemia * 1  17/70 (24.29%)  24
Hypocalcemia * 1  10/70 (14.29%)  12
Hypoglycemia * 1  2/70 (2.86%)  2
Hypokalemia * 1  13/70 (18.57%)  27
Hypomagnesemia * 1  26/70 (37.14%)  165
Hyponatremia * 1  23/70 (32.86%)  62
Hypophosphatemia * 1  6/70 (8.57%)  8
Serum calcium decreased * 2  1/70 (1.43%)  4
Serum magnesium decreased * 2  1/70 (1.43%)  3
Serum sodium decreased * 2  1/70 (1.43%)  4
Serum triglycerides increased * 2  1/70 (1.43%)  6
Musculoskeletal and connective tissue disorders   
Arthritis * 1  9/70 (12.86%)  74
Back pain * 1  17/70 (24.29%)  82
Bone pain * 1  4/70 (5.71%)  5
Chest wall pain * 1  1/70 (1.43%)  1
Joint disorder * 1  1/70 (1.43%)  1
Joint pain * 1  26/70 (37.14%)  182
Muscle weakness lower limb * 1  1/70 (1.43%)  1
Musculoskeletal disorder * 1  1/70 (1.43%)  3
Myalgia * 1  17/70 (24.29%)  73
Neck pain * 1  4/70 (5.71%)  14
Pain in extremity * 1  5/70 (7.14%)  17
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor flare * 1  1/70 (1.43%)  15
Tumor pain * 1  6/70 (8.57%)  27
Nervous system disorders   
Dizziness * 1  14/70 (20.00%)  38
Extrapyramidal disorder * 1  3/70 (4.29%)  4
Headache * 1  42/70 (60.00%)  234
Ischemia cerebrovascular * 1  1/70 (1.43%)  1
Memory impairment * 1  3/70 (4.29%)  5
Neurological disorder NOS * 1  1/70 (1.43%)  2
Olfactory nerve disorder * 1  1/70 (1.43%)  1
Peripheral sensory neuropathy * 1  18/70 (25.71%)  127
Sinus pain * 1  1/70 (1.43%)  6
Speech disorder * 1  1/70 (1.43%)  1
Taste alteration * 1  6/70 (8.57%)  30
Tremor * 1  1/70 (1.43%)  1
Psychiatric disorders   
Anxiety * 1  22/70 (31.43%)  124
Confusion * 1  1/70 (1.43%)  6
Depression * 1  13/70 (18.57%)  62
Insomnia * 1  19/70 (27.14%)  145
Renal and urinary disorders   
Bladder pain * 1  2/70 (2.86%)  5
Cystitis * 1  2/70 (2.86%)  5
Hemoglobinuria * 1  1/70 (1.43%)  3
Hemorrhage urinary tract * 1  10/70 (14.29%)  38
Kidney pain * 1  2/70 (2.86%)  31
Protein urine positive * 2  2/70 (2.86%)  13
Proteinuria * 1  30/70 (42.86%)  137
Ureteric obstruction * 1  1/70 (1.43%)  6
Urethral hemorrhage * 1  2/70 (2.86%)  2
Urethral pain * 2  2/70 (2.86%)  14
Urinary frequency * 2  5/70 (7.14%)  9
Urinary incontinence * 1  2/70 (2.86%)  12
Urine discoloration * 1  1/70 (1.43%)  1
Urogenital disorder * 1  1/70 (1.43%)  1
Reproductive system and breast disorders   
Breast pain * 1  2/70 (2.86%)  2
Pelvic pain * 1  2/70 (2.86%)  8
Vaginal discharge * 1  1/70 (1.43%)  2
Vaginal dryness * 1  2/70 (2.86%)  4
Vaginal hemorrhage * 1  2/70 (2.86%)  2
Vaginal inflammation * 1  1/70 (1.43%)  2
Vaginal pain * 1  2/70 (2.86%)  3
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis * 1  18/70 (25.71%)  57
Bronchial fistula * 1  1/70 (1.43%)  1
Cough * 1  23/70 (32.86%)  45
Dyspnea * 1  28/70 (40.00%)  112
Hemorrhage nasal * 1  11/70 (15.71%)  23
Laryngeal mucositis * 1  1/70 (1.43%)  2
Pharyngeal hemorrhage * 1  1/70 (1.43%)  1
Pharyngeal mucositis * 1  1/70 (1.43%)  1
Pharyngolaryngeal pain * 1  9/70 (12.86%)  13
Pleural effusion * 1  2/70 (2.86%)  3
Respiratory disorder * 1  1/70 (1.43%)  1
Respiratory tract hemorrhage * 1  3/70 (4.29%)  3
Voice alteration * 1  9/70 (12.86%)  22
Skin and subcutaneous tissue disorders   
Alopecia * 1  12/70 (17.14%)  115
Decubitus ulcer * 1  1/70 (1.43%)  1
Dry skin * 1  6/70 (8.57%)  23
Erythema multiforme * 1  1/70 (1.43%)  1
Nail disorder * 1  5/70 (7.14%)  17
Pain of skin * 1  3/70 (4.29%)  13
Petechiae * 1  2/70 (2.86%)  12
Photosensitivity * 1  1/70 (1.43%)  1
Pruritus * 1  4/70 (5.71%)  30
Rash desquamating * 1  12/70 (17.14%)  25
Skin disorder * 1  6/70 (8.57%)  20
Skin hypopigmentation * 1  2/70 (2.86%)  2
Sweating * 1  7/70 (10.00%)  17
Urticaria * 1  2/70 (2.86%)  2
Vascular disorders   
Flushing * 1  2/70 (2.86%)  2
Hemorrhage * 1  3/70 (4.29%)  6
Hot flashes * 1  10/70 (14.29%)  68
Hypertension * 1  27/70 (38.57%)  185
Hypotension * 1  1/70 (1.43%)  1
Vascular disorder * 1  1/70 (1.43%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
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: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072566     History of Changes
Other Study ID Numbers: NCI-2012-02562
NCI-2012-02562 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-5789
CHNMC-PHII-45
CDR0000340522
CCC-PHII-45
PHII-45 ( Other Identifier: City of Hope Comprehensive Cancer Center )
5789 ( Other Identifier: CTEP )
N01CM17101 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
First Submitted: November 4, 2003
First Posted: November 5, 2003
Results First Submitted: April 14, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015