Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 526 for:    "Primary Peritoneal Carcinoma"

Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors

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: NCT00520013
Recruitment Status : Completed
First Posted : August 23, 2007
Results First Posted : July 3, 2015
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Papillary Serous Mullerian Tumor
Clear Cell Mullerian Tumor
Interventions Drug: bevacizumab
Drug: erlotinib
Drug: paclitaxel
Drug: carboplatin
Enrollment 60
Recruitment Details Sixty patients were enrolled between Aug 3, 2007 and Jan 6, 2010.
Pre-assignment Details Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
Arm/Group Title Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib Carboplatin/Paclitaxel/Bevacizumab
Hide Arm/Group Description

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation: None

Period Title: Overall Study
Started 23 25 11 [1]
Treated 23 25 11
Completed 11 10 0
Not Completed 12 15 11
Reason Not Completed
Withdrawal by Subject             0             0             1
Adverse Event             2             10             7
Progressive Disease             7             3             0
Clinical Progression             3             1             0
Death             0             1             0
Physician Decision             0             0             3
[1]
Excludes a pt who went off-study (on reg day) due to consent that may not have been informed (ESL).
Arm/Group Title Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib Carboplatin/Paclitaxel/Bevacizumab Total
Hide Arm/Group Description

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

bevacizumab

paclitaxel

carboplatin

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

bevacizumab

erlotinib

paclitaxel

carboplatin

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation: None

bevacizumab

paclitaxel

carboplatin

Total of all reporting groups
Overall Number of Baseline Participants 23 25 11 59
Hide Baseline Analysis Population Description
The analysis dataset is comprised of treated patients.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 23 participants 25 participants 11 participants 59 participants
58
(48 to 63)
56
(49 to 61)
54
(51 to 59)
57
(49 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 11 participants 59 participants
Female
23
 100.0%
25
 100.0%
11
 100.0%
59
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 25 participants 11 participants 59 participants
23 25 11 59
Cancer Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 11 participants 59 participants
Primary peritoneal 4 1 1 6
Fallopian tube 5 4 1 10
Epithelial ovarian 10 17 8 35
Uterine papillary serous 2 1 1 4
Other (mixed, carcinosarcoma) 2 2 0 4
1.Primary Outcome
Title Consolidation Progression-Free Survival
Hide Description Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to >/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.
Time Frame Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of patients randomized to consolidation treatment.
Arm/Group Title Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Hide Arm/Group Description:

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

Overall Number of Participants Analyzed 23 25
Median (95% Confidence Interval)
Unit of Measure: months
13.3 [1] 
(10.1 to NA)
18.9 [1] 
(15.4 to NA)
[1]
PFS data was not mature enough to provide an upper bound on 95% CI. Also note per design each arm was separately compared to a historical control [PMID:7494563].
2.Primary Outcome
Title Consolidation Treatment-related Toxicity Rate
Hide Description Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.
Time Frame Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of patients who were randomized to consolidation treatment.
Arm/Group Title Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Hide Arm/Group Description:

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.4
(13.2 to 52.9)
72.0
(50.6 to 88.0)
3.Secondary Outcome
Title Consolidation Objective Response Rate
Hide Description Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample.
Time Frame Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all patient who started consolidation treatment.
Arm/Group Title Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Hide Arm/Group Description:

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of patients
0.65
(.43 to .84)
.60
(.39 to .79)
Time Frame Assessed each cycle throughout consolidation treatment from time of first dose and up to day 30 post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.
Adverse Event Reporting Description Serious and other AE data is only available for consolidation treatment reflecting the primary and secondary study objectives centered on the evaluation of consolidative regimens AE vs A.
 
Arm/Group Title Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Hide Arm/Group Description

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

All-Cause Mortality
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   7/23 (30.43%)   18/25 (72.00%) 
Blood and lymphatic system disorders     
Hemoglobin  1  0/23 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Colitis  1  0/23 (0.00%)  1/25 (4.00%) 
Diarrhea w/o prior colostomy  1  0/23 (0.00%)  5/25 (20.00%) 
Enteritis  1  0/23 (0.00%)  1/25 (4.00%) 
General disorders     
Fatigue  1  1/23 (4.35%)  1/25 (4.00%) 
Infections and infestations     
Infection-other  1  0/23 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications     
Wound - non-infectious  1  0/23 (0.00%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Hyponatremia  1  0/23 (0.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Extremity-limb, pain  1  0/23 (0.00%)  1/25 (4.00%) 
Joint, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Muscle, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Reproductive system and breast disorders     
Irregular menses  1  0/23 (0.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Nail changes  1  0/23 (0.00%)  1/25 (4.00%) 
Rash/desquamation  1  0/23 (0.00%)  1/25 (4.00%) 
Rash: acne/acneiform  1  0/23 (0.00%)  3/25 (12.00%) 
Vascular disorders     
Hypertension  1  6/23 (26.09%)  4/25 (16.00%) 
Hemorrhage-other  1  0/23 (0.00%)  1/25 (4.00%) 
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 0%
Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   23/23 (100.00%)   25/25 (100.00%) 
Blood and lymphatic system disorders     
Hemoglobin  1  8/23 (34.78%)  8/25 (32.00%) 
Lymphatics-other  1  0/23 (0.00%)  1/25 (4.00%) 
Cardiac disorders     
C-P arrest, non-fatal, cause unk  1  1/23 (4.35%)  0/25 (0.00%) 
Ear and labyrinth disorders     
Tinnitus  1  1/23 (4.35%)  0/25 (0.00%) 
Eye disorders     
Vision-blurred  1  2/23 (8.70%)  0/25 (0.00%) 
Gastrointestinal disorders     
Abdomen, pain  1  3/23 (13.04%)  1/25 (4.00%) 
Constipation  1  5/23 (21.74%)  6/25 (24.00%) 
Dental/teeth/peridontal  1  1/23 (4.35%)  0/25 (0.00%) 
Diarrhea w/o prior colostomy  1  5/23 (21.74%)  18/25 (72.00%) 
Dry mouth  1  1/23 (4.35%)  0/25 (0.00%) 
Dyspepsia  1  3/23 (13.04%)  0/25 (0.00%) 
Esophagitis  1  0/23 (0.00%)  1/25 (4.00%) 
GI-other  1  0/23 (0.00%)  3/25 (12.00%) 
Hemorrhoids  1  0/23 (0.00%)  3/25 (12.00%) 
Intestine, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Lip, pain  1  0/23 (0.00%)  1/25 (4.00%) 
Muco/stomatitis (symptom) oral cavity  1  1/23 (4.35%)  4/25 (16.00%) 
Muco/stomatitis (symptom) stomach  1  0/23 (0.00%)  1/25 (4.00%) 
Muco/stomatitis by exam, oral cavity  1  0/23 (0.00%)  2/25 (8.00%) 
Nausea  1  5/23 (21.74%)  9/25 (36.00%) 
Oral cavity, hemorrhage  1  3/23 (13.04%)  1/25 (4.00%) 
Oral cavity, pain  1  0/23 (0.00%)  3/25 (12.00%) 
Oral gums, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Rectum, hemorrhage  1  1/23 (4.35%)  0/25 (0.00%) 
Salivary  1  0/23 (0.00%)  1/25 (4.00%) 
Vomiting  1  2/23 (8.70%)  1/25 (4.00%) 
General disorders     
Chest/thoracic pain NOS  1  0/23 (0.00%)  1/25 (4.00%) 
Constitutional, other  1  0/23 (0.00%)  1/25 (4.00%) 
Edema limb  1  1/23 (4.35%)  3/25 (12.00%) 
Face, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Fatigue  1  18/23 (78.26%)  21/25 (84.00%) 
Fever w/o neutropenia  1  0/23 (0.00%)  2/25 (8.00%) 
Pain-other  1  2/23 (8.70%)  1/25 (4.00%) 
Rigors/chills  1  0/23 (0.00%)  2/25 (8.00%) 
Infections and infestations     
Infection Gr0-2 neut, lip/perioral  1  0/23 (0.00%)  1/25 (4.00%) 
Infection Gr0-2 neut, meninges  1  0/23 (0.00%)  1/25 (4.00%) 
Infection Gr0-2 neut, skin  1  0/23 (0.00%)  1/25 (4.00%) 
Infection Gr0-2 neut, urinary tract  1  1/23 (4.35%)  1/25 (4.00%) 
Infection Gr0-2 neut, wound  1  0/23 (0.00%)  1/25 (4.00%) 
Infection w/ gr3-4 neut, anal/perianal  1  0/23 (0.00%)  1/25 (4.00%) 
Infection w/ gr3-4 neut, skin  1  0/23 (0.00%)  1/25 (4.00%) 
Infection w/ unk ANC ungual (nails)  1  0/23 (0.00%)  2/25 (8.00%) 
Infection-other  1  0/23 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications     
Chemoradiation dermatitis  1  0/23 (0.00%)  1/25 (4.00%) 
Investigations     
Alkaline phosphatase  1  0/23 (0.00%)  1/25 (4.00%) 
ALT, SGPT  1  0/23 (0.00%)  1/25 (4.00%) 
AST, SGOT  1  0/23 (0.00%)  2/25 (8.00%) 
Bilirubin  1  0/23 (0.00%)  1/25 (4.00%) 
Leukocytes  1  3/23 (13.04%)  5/25 (20.00%) 
Metabolic/Laboratory-other  1  0/23 (0.00%)  1/25 (4.00%) 
Neutrophils  1  1/23 (4.35%)  5/25 (20.00%) 
Platelets  1  5/23 (21.74%)  1/25 (4.00%) 
Weight loss  1  0/23 (0.00%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Anorexia  1  2/23 (8.70%)  5/25 (20.00%) 
Bicarbonate  1  1/23 (4.35%)  0/25 (0.00%) 
Dehydration  1  0/23 (0.00%)  1/25 (4.00%) 
Hyperglycemia  1  4/23 (17.39%)  2/25 (8.00%) 
Hyperkalemia  1  1/23 (4.35%)  0/25 (0.00%) 
Hypermagnesemia  1  0/23 (0.00%)  1/25 (4.00%) 
Hypernatremia  1  1/23 (4.35%)  1/25 (4.00%) 
Hypoalbuminemia  1  0/23 (0.00%)  1/25 (4.00%) 
Hypoglycemia  1  1/23 (4.35%)  0/25 (0.00%) 
Hypokalemia  1  0/23 (0.00%)  1/25 (4.00%) 
Hypomagnesemia  1  7/23 (30.43%)  8/25 (32.00%) 
Hyponatremia  1  2/23 (8.70%)  3/25 (12.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/23 (0.00%)  1/25 (4.00%) 
Bone, pain  1  0/23 (0.00%)  1/25 (4.00%) 
Extremity-limb, pain  1  2/23 (8.70%)  5/25 (20.00%) 
Joint, pain  1  12/23 (52.17%)  7/25 (28.00%) 
Joint-function  1  0/23 (0.00%)  3/25 (12.00%) 
Muscle, pain  1  6/23 (26.09%)  4/25 (16.00%) 
Musculoskeletal/soft tissue-other  1  0/23 (0.00%)  2/25 (8.00%) 
Neck, pain  1  2/23 (8.70%)  0/25 (0.00%) 
Nonneuropathic generalized weakness  1  0/23 (0.00%)  1/25 (4.00%) 
Nonneuropathic upper extr muscle weak  1  0/23 (0.00%)  2/25 (8.00%) 
Nervous system disorders     
Dizziness  1  1/23 (4.35%)  1/25 (4.00%) 
Head/headache  1  6/23 (26.09%)  4/25 (16.00%) 
Neurologic-other  1  1/23 (4.35%)  0/25 (0.00%) 
Neuropathy-motor  1  2/23 (8.70%)  3/25 (12.00%) 
Neuropathy-sensory  1  14/23 (60.87%)  12/25 (48.00%) 
Sinus, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Taste disturbance  1  1/23 (4.35%)  3/25 (12.00%) 
Psychiatric disorders     
Anxiety  1  5/23 (21.74%)  2/25 (8.00%) 
Confusion  1  0/23 (0.00%)  1/25 (4.00%) 
Depression  1  1/23 (4.35%)  0/25 (0.00%) 
Insomnia  1  2/23 (8.70%)  1/25 (4.00%) 
Libido  1  0/23 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Bladder, pain  1  0/23 (0.00%)  1/25 (4.00%) 
Proteinuria  1  4/23 (17.39%)  2/25 (8.00%) 
Renal/GU-other  1  1/23 (4.35%)  1/25 (4.00%) 
Urinary frequency/urgency  1  1/23 (4.35%)  1/25 (4.00%) 
Urinary hemorrhage NOS  1  1/23 (4.35%)  0/25 (0.00%) 
Reproductive system and breast disorders     
Vagina, hemorrhage  1  2/23 (8.70%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/23 (4.35%)  2/25 (8.00%) 
Cough  1  1/23 (4.35%)  0/25 (0.00%) 
Dyspnea  1  2/23 (8.70%)  0/25 (0.00%) 
Nose, hemorrhage  1  13/23 (56.52%)  7/25 (28.00%) 
Pulmonary/Upper Respiratory-other  1  0/23 (0.00%)  1/25 (4.00%) 
Throat/pharynx/larynax, pain  1  1/23 (4.35%)  0/25 (0.00%) 
Voice changes/dysarthria  1  2/23 (8.70%)  3/25 (12.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  12/23 (52.17%)  11/25 (44.00%) 
Dry skin  1  1/23 (4.35%)  11/25 (44.00%) 
Erythema multiforme  1  0/23 (0.00%)  1/25 (4.00%) 
Hand-foot reaction  1  0/23 (0.00%)  1/25 (4.00%) 
Nail changes  1  0/23 (0.00%)  3/25 (12.00%) 
Photosensitivity  1  0/23 (0.00%)  1/25 (4.00%) 
Pruritus/itching  1  1/23 (4.35%)  5/25 (20.00%) 
Rash/desquamation  1  1/23 (4.35%)  8/25 (32.00%) 
Rash: acne/acneiform  1  1/23 (4.35%)  16/25 (64.00%) 
Skin breakdown/decubitus ulcer  1  0/23 (0.00%)  1/25 (4.00%) 
Skin, pain  1  0/23 (0.00%)  1/25 (4.00%) 
Skin-other  1  0/23 (0.00%)  4/25 (16.00%) 
Urticaria  1  1/23 (4.35%)  0/25 (0.00%) 
Vascular disorders     
Hemorrhage-other  1  1/23 (4.35%)  0/25 (0.00%) 
Hypertension  1  9/23 (39.13%)  9/25 (36.00%) 
Hypotension  1  0/23 (0.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Susana M. Campos, MD, MPH
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5269
Responsible Party: Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00520013     History of Changes
Other Study ID Numbers: 07-039
First Submitted: August 22, 2007
First Posted: August 23, 2007
Results First Submitted: April 8, 2015
Results First Posted: July 3, 2015
Last Update Posted: July 27, 2018