Trial Outcomes & Findings for Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy (NCT NCT00049257)

Last Updated: 2020-09-01

Results Overview

PSA response is defined as a decline from the baseline value of \>=50% confirmed by a second PSA value 4 or more weeks later.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.

Results posted on

2020-09-01

Participant Flow

Date of recruitment period: 10/02/2002- 5/25/2006. Types of location: Academic Medical clinics and community medical clinics. This study has 1 treatment arm; therefore randomization procedures were not utilized and all participants were enrolled to the same treatment regimen.

Participant milestones

Participant milestones
Measure	Carboplatin, Paclitaxel Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Carboplatin, Paclitaxel STARTED	58
Carboplatin, Paclitaxel COMPLETED	45
Carboplatin, Paclitaxel NOT COMPLETED	13
Follow-up Period for Survival Status STARTED	45
Follow-up Period for Survival Status COMPLETED	41
Follow-up Period for Survival Status NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Carboplatin, Paclitaxel Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Carboplatin, Paclitaxel Withdrawal by Subject	10
Carboplatin, Paclitaxel Lost to Follow-up	1
Carboplatin, Paclitaxel Death	2
Follow-up Period for Survival Status Lost to Follow-up	4

Baseline Characteristics

Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carboplatin, Paclitaxel n=58 Participants Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.

PSA response is defined as a decline from the baseline value of \>=50% confirmed by a second PSA value 4 or more weeks later.

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel n=58 Participants Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Prostate-specific Antigen (PSA) Response Rate Participants with PSA response	28 participants
Prostate-specific Antigen (PSA) Response Rate Participants with no PSA response	30 participants

PRIMARY outcome

Timeframe: Evaluated every 28 days during Treatment Period

In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by \>=5ng/ml, confirmed by a second value at \>=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is \>=5ng/ml and is confirmed by a second value at \>=4 week intervals.

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel n=58 Participants Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Time to PSA Progression	115 days Interval 26.0 to 394.0

SECONDARY outcome

Timeframe: Evaluated every 12 weeks during Treatment Period

Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \<50% and lesions with an estimated increase of \<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \>=25% or appearance of new lesions. Need for radiotherapy is considered PD.

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel n=53 Participants Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Objective Response Rate Participants with Complete Response	1 participants
Objective Response Rate Participants with Partial Response	12 participants
Objective Response Rate Participants with Stable Disease	33 participants
Objective Response Rate Participants with Progression of Disease	7 participants

SECONDARY outcome

Timeframe: Assessed every two months after completion of study treatment for 4 years

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel n=58 Participants Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Overall Survival Rate Deceased	46 participants
Overall Survival Rate Alive	1 participants
Overall Survival Rate Lost to Follow-up	1 participants
Overall Survival Rate Withdrawal by subject	10 participants

Adverse Events

Carboplatin, Paclitaxel

Serious events: 14 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Carboplatin, Paclitaxel n=58 participants at risk Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Cardiac disorders Deep Verin Thrombosis with Pulmonary Embolism	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders Paresthesia	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Blood and lymphatic system disorders Subarachnoid Hemorrhage	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Cardiac disorders Angina	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Renal and urinary disorders Urinary retention with acute hematuria	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Cardiac disorders Death secondary to cardiac arrest	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders Dehydration	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Immune system disorders Anaphylaxix	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Infections and infestations Febrile Neutropenia	3.4% 2/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders Hyperglycemia and diabetic management	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders Constipation	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Musculoskeletal and connective tissue disorders back pain	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders Gall stones	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders spinal injury; inability to walk or stand ultimately caused death	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	1.7% 1/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.

Other adverse events

Other adverse events
Measure	Carboplatin, Paclitaxel n=58 participants at risk Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
Blood and lymphatic system disorders Neutropenia	86.2% 50/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Blood and lymphatic system disorders anemia	79.3% 46/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Skin and subcutaneous tissue disorders Alopecia	77.6% 45/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders Fatigue	75.9% 44/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	60.3% 35/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders Neuropathy-sensory	58.6% 34/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders Diarrhea	56.9% 33/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Blood and lymphatic system disorders Leukopenia	56.9% 33/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders Anorexia	53.4% 31/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders Nausea	51.7% 30/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders Insomnia	39.7% 23/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Blood and lymphatic system disorders Edema, limb	37.9% 22/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders constipation	36.2% 21/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain, extremity-lower	34.5% 20/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders Pain, Not otherwise specified	34.5% 20/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders mood alteration-depression	27.6% 16/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders vomiting	27.6% 16/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders taste alteration	22.4% 13/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders dizziness	20.7% 12/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hyperglycemia	20.7% 12/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Renal and urinary disorders hematuria	19.0% 11/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Blood and lymphatic system disorders hemorrhage pulmonary- nose	19.0% 11/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain, head	19.0% 11/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders neuropathy-motor	19.0% 11/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders dyspepsia	15.5% 9/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders fever	15.5% 9/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Infections and infestations infection-upper airway not otherwise specified	15.5% 9/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Skin and subcutaneous tissue disorders rash	15.5% 9/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Musculoskeletal and connective tissue disorders pain, back	13.8% 8/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Musculoskeletal and connective tissue disorders pain, muscle	13.8% 8/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Musculoskeletal and connective tissue disorders pain, shoulder	13.8% 8/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Renal and urinary disorders urinary frequency	20.7% 12/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders cold symptoms	12.1% 7/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Respiratory, thoracic and mediastinal disorders cough	12.1% 7/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Infections and infestations infection- urinary tract not otherwise specified	12.1% 7/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Nervous system disorders mood alteration- anxiety	12.1% 7/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Immune system disorders allergic rhinitis	10.3% 6/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Respiratory, thoracic and mediastinal disorders congestion	10.3% 6/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain, abdomen	10.3% 6/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders sweating	10.3% 6/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Immune system disorders allergic reaction	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders ALT, elevated	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders dehydration	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hypocalcemia	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hypokalemia	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Cardiac disorders hypotension	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain, chest- non-cardiac	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders sore throat	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Skin and subcutaneous tissue disorders pruritis	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders weight loss	8.6% 5/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders alkaline phosphatase, elevated	6.9% 4/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders AST, elevated	6.9% 4/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Eye disorders blurred vision	6.9% 4/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders dry mouth	6.9% 4/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hypoalbuminemia	6.9% 4/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Renal and urinary disorders Urinary retention	6.9% 4/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders cachexia	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain-urination	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders flatulence	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders flu-like syndrome	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders gastroenteritis	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hyperkalemia	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hyperphosphatemia	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hypomagnesia	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Metabolism and nutrition disorders hyponatremia	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Gastrointestinal disorders mucositis-oral cavity	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Skin and subcutaneous tissue disorders nail changes	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain, bone	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders pain, neck	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
General disorders rigors/chills	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Respiratory, thoracic and mediastinal disorders voice changes	5.2% 3/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.
Respiratory, thoracic and mediastinal disorders dyspnea	20.7% 12/58 • Adverse events collected between 11/12/2002 and 08/06/2007, therefore AE reporting period is 4.7 years or 4 years and 9 months, approximately Systemic adverse event assessment occurred every 28 days through investigator assessment during treatment period and once within 30 days after last administration of study treatment.

Additional Information

Dr. Fairooz Kabbinavar, Chief Medical Officer

Translational Oncology Research International

Phone: 310 824 1934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The obligations of confidentiality shall apply for a period of 5 yrs beyond termination of Agreement between Sponsor and Investigator,but do not apply to the extent information:is or later becomes known to public;is obtained from a third party without restriction who had a legal right to disclose;is possessed by Investigators,as demonstrated by recipient's written records predating receipt from Sponsor;is required to be disclosed pursuant to a subpoena, law, regulation or other legal proceeding.
Publication restrictions are in place

Restriction type: OTHER