Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00301964
• Collaborator: Gynecologic Oncology Group (Other)
• Enrollment: 56
• Location: 1
• Arm: 1
• Duration (Months): 64
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This phase II trial is studying how well bevacizumab works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Endometrial Carcinoma	Biological: bevacizumab; Other: laboratory biomarker analysis	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Assess the activity of bevacizumab, in terms of 6-month progression-free survival rate and objective tumor response, in patients with recurrent or persistent endometrial cancer.

2. Determine the nature and degree of toxicity of bevacizumab in these patients.

SECONDARY OBJECTIVES:

1. Determine the duration of progression-free survival and overall survival of these patients.

2. Determine the effects of prognostic factors, including performance status and histological grade.

OUTLINE:

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Bevacizumab (NCI-Supplied Agent: NSC# 704865, IND # 7921) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (bevacizumab) Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.	Biological: bevacizumab; Given IV; Other Names: anti-VEGF humanized monoclonal antibody anti-VEGF monoclonal antibody Avastin rhuMAb VEGF ; Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival Greater Than 6 Months [6 months]

   Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

2. Best Tumor Response [study entry through completion]

   Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

3. Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients. [Up to 5 years]

Secondary Outcome Measures

1. Progression-free Survival [Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.]

   Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

2. Overall Survival [Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.]

   Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

3. Initial Performance Status [Baseline]

   Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.

4. Histologic Grade [Baseline]

   G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Recurrent or persistent endometrial carcinoma with histologic confirmation of the original primary tumor

• Refractory to curative therapy or established treatments

• Measurable disease

• At least one non previously irradiated lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• Previously irradiated lesion allowed provided disease progression is documented or a biopsy obtained to confirm persistent disease ≥ 90 days after completion of prior radiotherapy

• Must have received 1 prior chemotherapy regimen for endometrial carcinoma

• May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment

• Not eligible for a higher priority GOG protocol, if one exists

• No tumor involving major vessels

• No prior history or evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases

• GOG performance status (PS) 0-2 (if received 1 prior treatment regimen)

• GOG PS 0-1 (if received 2 prior treatment regimens)

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Serum bilirubin ≤ 1.5 times ULN

• SGOT and alkaline phosphatase ≤ 2.5 times ULN

• Urine protein:creatinine ratio < 1.0

• INR < 1.5 (or in-range, usually between 2 and 3, if the patient is on a stable dose of therapeutic warfarin)

• PTT < 1.5 times ULN

• No active infection requiring antibiotics

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy

• No serious nonhealing wound or ulcer, including any of the following:

• History of abdominal fistula

• Gastrointestinal perforation

• Intra-abdominal abscess within the past 28 days

• No serious nonhealing bone fracture

• No active bleeding or pathologic conditions that carry high risk of bleeding, including known bleeding disorder or coagulopathy

• No clinically significant cardiovascular disease, including any of the following:

• Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg

• Myocardial infarction or unstable angina within the past 6 months

• New York Heart Association class II-IV congestive heart failure

• Serious cardiac arrhythmia requiring medication

• Ejection fraction < 50% and received prior anthracycline (including doxorubicin and/or doxorubicin HCl liposomal)

• Grade 2 or greater peripheral vascular disease

• History of cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months

• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies

• No significant traumatic injury within the past 28 days

• See Disease Characteristics

• Recovered from recent surgery, radiotherapy, or chemotherapy

• Hormonal therapy directed at the malignant tumor must be discontinued ≥ 1 week prior to registration

• Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued ≥ 3 weeks prior to registration

• No prior chemotherapy or radiotherapy to any portion of the abdominal cavity or pelvis

• Prior chemotherapy or radiotherapy for localized cancer of the breast, head and neck, or skin for which the patient remains free of recurrent or metastatic disease is allowed provided it was completed ≥ 3 years prior to study

• No prior cancer treatment that contraindicates study therapy

• No prior bevacizumab or other vascular endothelial growth factor (VEGF) pathway-targeted therapy

• One additional prior cytotoxic regimen for recurrent or persistent endometrial cancer allowed, including any agent that targets the genetic and/or mitotic apparatus of dividing cells resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa

• No prior noncytotoxic chemotherapy for recurrent or persistent disease

• More than 28 days since major surgical procedure or open biopsy

• More than 7 days since minor surgical procedures, fine needle aspirates, or core biopsies

• No concurrent major surgical procedure

• No concurrent prophylactic filgrastim (G-CSF) or thrombopoietic agents

• No concurrent amifostine or other protective reagents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

• National Cancer Institute (NCI)
• Gynecologic Oncology Group

Investigators

• Principal Investigator: Carol Aghajanian, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00301964
• Other Study ID Numbers: NCI-2012-02692; NCI-2012-02692; CDR0000465502; GOG-0229E; GOG-0229E; U10CA027469
• First Posted: Mar 13, 2006
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Carcinoma; Endometrial Neoplasms; Recurrence; Bevacizumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal

Study Results

Participant Flow

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Period Title: Overall Study
STARTED	56
COMPLETED	52
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Overall Participants	52
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (10.3)
Age, Customized (participants) [Number]
30-39 years	1 1.9%
40-49 years	4 7.7%
50-59 years	13 25%
60-69 years	22 42.3%
70-79 years	11 21.2%
80-89 years	1 1.9%
Sex: Female, Male (Count of Participants)
Female	52 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	52 100%
Cell Type (participants) [Number]
Adenocarcinoma, Unspecified	1 1.9%
Clear Cell Carcinoma	4 7.7%
Endometrioid Adenocarcinoma	26 50%
Mucinous Adenocarcinoma	1 1.9%
Mixed Epithelial Carcinoma	5 9.6%
Undifferentiated Carcinoma	1 1.9%
Serous Adenocarcinoma	14 26.9%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival Greater Than 6 Months
Description	Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Total number of eligible and evaluable participants

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Measure Participants	52
No	31 59.6%
Yes	21 40.4%

2. Primary Outcome

Title	Best Tumor Response
Description	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Time Frame	study entry through completion

Outcome Measure Data

Analysis Population Description

Total number eligible and evaluable participants

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Measure Participants	52
Complete Response	1 1.9%
Partial Response	6 11.5%
Stable Disease	26 50%
Disease Progression	17 32.7%
Indeterminate	2 3.8%

3. Primary Outcome

Title	Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Grade 0	Grade 1 (CTCAE v 3.0)	Grade 2 (CTCAE v 3.0)	Grade 3 (CTCAE v 3.0)	Grade 4 (CTCAE v 3.0)	Grade 5 (CTCAE v 3.0)
Arm/Group Description	Number of patients who did not experience the specified AE.	Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Measure Participants	52	52	52	52	52	52
Leukopenia	48 92.3%	4 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Thrombocytopenia	46 88.5%	6 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Neutropenia	50 96.2%	2 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Anemia	36 69.2%	9 NaN	6 NaN	1 NaN	0 NaN	0 NaN
Hypersensitivity	50 96.2%	1 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Rhinitis	50 96.2%	1 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Hypertension	43 82.7%	2 NaN	3 NaN	4 NaN	0 NaN	0 NaN
Hypotension	50 96.2%	1 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Other Cardiac	48 92.3%	3 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Constitutional	17 32.7%	23 NaN	10 NaN	2 NaN	0 NaN	0 NaN
Dermatologic	47 90.4%	5 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Nausea	44 84.6%	6 NaN	2 NaN	0 NaN	0 NaN	0 NaN
Vomiting	46 88.5%	4 NaN	2 NaN	0 NaN	0 NaN	0 NaN
GI	28 53.8%	21 NaN	2 NaN	1 NaN	0 NaN	0 NaN
Hemorrhage	40 76.9%	9 NaN	1 NaN	1 NaN	1 NaN	0 NaN
Hepatobiliary	51 98.1%	0 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Infection	47 90.4%	0 NaN	5 NaN	0 NaN	0 NaN	0 NaN
Edema (limb)	48 92.3%	3 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Metabolic	30 57.7%	16 NaN	3 NaN	1 NaN	2 NaN	0 NaN
Musculoskeletal	48 92.3%	1 NaN	0 NaN	3 NaN	0 NaN	0 NaN
Neurosensory	48 92.3%	4 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Other neurologic	47 90.4%	4 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Ocular/visual	49 94.2%	3 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Pain	33 63.5%	11 NaN	4 NaN	4 NaN	0 NaN	0 NaN

4. Secondary Outcome

Title	Progression-free Survival
Description	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame	Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients.

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Measure Participants	52
Median (Inter-Quartile Range) [months]	4.17

5. Secondary Outcome

Title	Overall Survival
Description	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients.

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Measure Participants	52
Median (Inter-Quartile Range) [months]	10.55

6. Secondary Outcome

Title	Initial Performance Status
Description	Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Measure Participants	52
Performance Status 0	34 65.4%
Performance Status 1	17 32.7%
Performance Status 2	1 1.9%

7. Secondary Outcome

Title	Histologic Grade
Description	G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
Measure Participants	52
Grade 1	3 5.8%
Grade 2	12 23.1%
Grade 3	37 71.2%

Adverse Events

Time Frame	from study entry up to 5 years after stopping study treatment
Arm/Group Title	Treatment (Bevacizumab)
Arm/Group Description	Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
All Cause Mortality
	Treatment (Bevacizumab)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Bevacizumab)
	Affected / at Risk (%)	# Events
Total	18/52 (34.6%)
Cardiac disorders
Lt Ventricular Systolic Dysfunction	1/52 (1.9%)
Hypotension	1/52 (1.9%)
Gastrointestinal disorders
Obstruction, Gi - Rectum	1/52 (1.9%)
Obstruction, Gi - Small Bowel Nos	2/52 (3.8%)
Vomiting	1/52 (1.9%)
Gastrointestinal - Other	1/52 (1.9%)
General disorders
Death No Ctcae Term - Disease Progression Nos	2/52 (3.8%)
Pain: Extremity-Limb	1/52 (1.9%)
Pain: Abdominal Pain Nos	1/52 (1.9%)
Hepatobiliary disorders
Cholecystitis	1/52 (1.9%)
Metabolism and nutrition disorders
Proteinuria	1/52 (1.9%)
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized	1/52 (1.9%)
Muscle Weakness - Extremity-Lower	1/52 (1.9%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm	1/52 (1.9%)
Hypoxia	1/52 (1.9%)
Vascular disorders
Hemorrhage, Gu - Vagina	1/52 (1.9%)
Hemorrhage/Pulmonary - Lung	1/52 (1.9%)
Hemorrhage, Gi - Stomach	1/52 (1.9%)
Thrombosis/Thrombus/Embolism	1/52 (1.9%)
Other (Not Including Serious) Adverse Events
	Treatment (Bevacizumab)
	Affected / at Risk (%)	# Events
Total	51/52 (98.1%)
Blood and lymphatic system disorders
Neutrophils	2/52 (3.8%)
Platelets	7/52 (13.5%)
Leukocytes	8/52 (15.4%)
Hemoglobin	24/52 (46.2%)
Edema: Limb	7/52 (13.5%)
Cardiac disorders
Palpitations	5/52 (9.6%)
S/N Arrhythmia: Sinus Bradycardia	1/52 (1.9%)
S/N Arrhythmia: Atrial Tachycardia	1/52 (1.9%)
Hypertension	12/52 (23.1%)
Lt Ventricular Systolic Dysfunction	1/52 (1.9%)
Hypotension	2/52 (3.8%)
Ear and labyrinth disorders
Auditory/Ear - Other	2/52 (3.8%)
Hearing (Without Monitoring Program)	1/52 (1.9%)
Tinnitus	3/52 (5.8%)
Endocrine disorders
Hot Flashes	2/52 (3.8%)
Hypothyroidism	1/52 (1.9%)
Eye disorders
Ocular/Visual - Other	3/52 (5.8%)
Dry Eye	3/52 (5.8%)
Photophobia	1/52 (1.9%)
Flashing Lights/Floaters	2/52 (3.8%)
Blurred Vision	7/52 (13.5%)
Eyelid Dysfunction	1/52 (1.9%)
Gastrointestinal disorders
Gastritis	2/52 (3.8%)
Heartburn	6/52 (11.5%)
Mucositis (Functional/Sympt) - Esophagus	1/52 (1.9%)
Ascites	1/52 (1.9%)
Distention	1/52 (1.9%)
Taste Alteration	4/52 (7.7%)
Dry Mouth	1/52 (1.9%)
Mucositis (Functional/Sympt) - Oral Cavity	10/52 (19.2%)
Mucositis (Clinical Exam) - Oral Cavity	6/52 (11.5%)
Vomiting	12/52 (23.1%)
Anorexia	11/52 (21.2%)
Dehydration	3/52 (5.8%)
Constipation	15/52 (28.8%)
Nausea	19/52 (36.5%)
Diarrhea	17/52 (32.7%)
General disorders
Sweating	3/52 (5.8%)
Weight Gain	1/52 (1.9%)
Fever	6/52 (11.5%)
Weight Loss	4/52 (7.7%)
Rigors/Chills	4/52 (7.7%)
Fatigue	38/52 (73.1%)
Insomnia	8/52 (15.4%)
Death No Ctcae Term - Disease Progression Nos	1/52 (1.9%)
Pain - Other	1/52 (1.9%)
Pain: Pelvis	3/52 (5.8%)
Pain: Chest /Thorax Nos	2/52 (3.8%)
Pain: Chest Wall	2/52 (3.8%)
Pain: Head/Headache	16/52 (30.8%)
Pain: Neck	3/52 (5.8%)
Pain: Extremity-Limb	9/52 (17.3%)
Pain: Buttock	1/52 (1.9%)
Pain: Back	10/52 (19.2%)
Pain: Joint	6/52 (11.5%)
Pain: Bone	2/52 (3.8%)
Pain: Stomach	3/52 (5.8%)
Pain: Rectum	1/52 (1.9%)
Pain: Abdominal Pain Nos	13/52 (25%)
Pain: Muscle	5/52 (9.6%)
Pain: Neuralgia	2/52 (3.8%)
Immune system disorders
Allergic Reaction/Hypersensitivity	4/52 (7.7%)
Rhinitis	4/52 (7.7%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	2/52 (3.8%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vein	1/52 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos	1/52 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1/52 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	3/52 (5.8%)
Inf Unknown Anc: Upper Airway Nos	1/52 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	2/52 (3.8%)
Inf Unknown Anc: Mucosa	1/52 (1.9%)
Inf Unknown Anc: Urinary Tract Nos	1/52 (1.9%)
Inf Unknown Anc: Oral Cavity-Gums	1/52 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	2/52 (3.8%)
Metabolism and nutrition disorders
Ast	8/52 (15.4%)
Metabolic/Laboratory - Other	2/52 (3.8%)
Cholesterol,serum High	1/52 (1.9%)
Proteinuria	5/52 (9.6%)
Creatinine	9/52 (17.3%)
Hypoalbuminemia	17/52 (32.7%)
Ggt	1/52 (1.9%)
Alt	4/52 (7.7%)
Alkaline Phosphatase	9/52 (17.3%)
Bilirubin	3/52 (5.8%)
Lipase	1/52 (1.9%)
Hypermagnesemia	1/52 (1.9%)
Hypophosphatemia	4/52 (7.7%)
Hyponatremia	15/52 (28.8%)
Hyperuricemia	1/52 (1.9%)
Bicarbonate, Serum-Low	1/52 (1.9%)
Amylase	1/52 (1.9%)
Hypernatremia	1/52 (1.9%)
Hypocalcemia	10/52 (19.2%)
Hyperkalemia	2/52 (3.8%)
Hyperglycemia	14/52 (26.9%)
Hypokalemia	4/52 (7.7%)
Hypoglycemia	1/52 (1.9%)
Hypercalcemia	4/52 (7.7%)
Hypomagnesemia	11/52 (21.2%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other	1/52 (1.9%)
Joint-Function	1/52 (1.9%)
Gait/Walking	2/52 (3.8%)
Cervical Spine Rom	1/52 (1.9%)
Arthritis	4/52 (7.7%)
Muscle Weakness - Whole Body/Generalized	2/52 (3.8%)
Muscle Weakness - Extremity-Upper	1/52 (1.9%)
Muscle Weakness - Extremity-Lower	3/52 (5.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx	1/52 (1.9%)
Nervous system disorders
Involuntary Movement	1/52 (1.9%)
Mood Alteration - Depression	7/52 (13.5%)
Mood Alteration - Anxiety	7/52 (13.5%)
Memory Impairment	5/52 (9.6%)
Dizziness	5/52 (9.6%)
Neuropathy-Sensory	13/52 (25%)
Neuropathy-Motor	3/52 (5.8%)
Renal and urinary disorders
Leak, Gu - Urethra	1/52 (1.9%)
Urinary Retention	1/52 (1.9%)
Obstruction, Gu - Ureter	1/52 (1.9%)
Incontinence, Urinary	1/52 (1.9%)
Urinary Frequency	3/52 (5.8%)
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions	3/52 (5.8%)
Voice Changes	4/52 (7.7%)
Cough	12/52 (23.1%)
Dyspnea	17/52 (32.7%)
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)	9/52 (17.3%)
Bruising	1/52 (1.9%)
Acne	1/52 (1.9%)
Rash	8/52 (15.4%)
Dry Skin	4/52 (7.7%)
Pruritus	2/52 (3.8%)
Flushing	1/52 (1.9%)
Ulceration	1/52 (1.9%)
Vascular disorders
Inr	1/52 (1.9%)
Hemorrhage, Gu - Urinary Nos	2/52 (3.8%)
Hemorrhage, Gu - Vagina	6/52 (11.5%)
Hemorrhage, Gi - Rectum	4/52 (7.7%)
Hemorrhage/Pulmonary - Respiratory Tract Nos	2/52 (3.8%)
Hemorrhage/Pulmonary - Nose	6/52 (11.5%)
Hemorrhage, Gi - Anus	2/52 (3.8%)
Hemorrhage, Gi - Oral Cavity	2/52 (3.8%)
Hemorrhage/Bleeding - Other	1/52 (1.9%)
Thrombosis/Thrombus/Embolism	2/52 (3.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.