Skip to content

Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Bevacizumab (NCI-Supplied Agent: NSC# 704865, IND # 7921) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00301964
Enrollment
56
Registered
2006-03-13
Start date
2006-03-31
Completion date
2011-07-31
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Endometrial Carcinoma

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.

Detailed description

PRIMARY OBJECTIVES: I. 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. II. Determine the nature and degree of toxicity of bevacizumab in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of these patients. II. 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.

Interventions

BIOLOGICALbevacizumab

Given IV

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

Gynecologic Oncology Group
CollaboratorNETWORK
National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Progression-free Survival Greater Than 6 Months6 monthsDisease 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.
Best Tumor Responsestudy entry through completionResponse 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.
Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Up to 5 years

Secondary

MeasureTime frameDescription
Progression-free SurvivalEvery 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.
Histologic GradeBaselineG1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.
Overall SurvivalEvery 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.
Initial Performance StatusBaselinePerformance 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. bevacizumab: Given IV laboratory biomarker analysis: Correlative studies
52
Total52

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyInadequate pathology1
Overall StudySecond primary2
Overall StudyWrong primary1

Baseline characteristics

CharacteristicTreatment (Bevacizumab)
Age, Continuous62.3 years
STANDARD_DEVIATION 10.3
Age, Customized
30-39 years
1 participants
Age, Customized
40-49 years
4 participants
Age, Customized
50-59 years
13 participants
Age, Customized
60-69 years
22 participants
Age, Customized
70-79 years
11 participants
Age, Customized
80-89 years
1 participants
Cell Type
Adenocarcinoma, Unspecified
1 participants
Cell Type
Clear Cell Carcinoma
4 participants
Cell Type
Endometrioid Adenocarcinoma
26 participants
Cell Type
Mixed Epithelial Carcinoma
5 participants
Cell Type
Mucinous Adenocarcinoma
1 participants
Cell Type
Serous Adenocarcinoma
14 participants
Cell Type
Undifferentiated Carcinoma
1 participants
Region of Enrollment
United States
52 participants
Sex: Female, Male
Female
52 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
51 / 52
serious
Total, serious adverse events
18 / 52

Outcome results

Primary

Best Tumor Response

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

Population: Total number eligible and evaluable participants

ArmMeasureGroupValue (NUMBER)
Treatment (Bevacizumab)Best Tumor ResponseComplete Response1 participants
Treatment (Bevacizumab)Best Tumor ResponsePartial Response6 participants
Treatment (Bevacizumab)Best Tumor ResponseStable Disease26 participants
Treatment (Bevacizumab)Best Tumor ResponseDisease Progression17 participants
Treatment (Bevacizumab)Best Tumor ResponseIndeterminate2 participants
Primary

Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.

Time frame: Up to 5 years

Population: Eligible and treated patients

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hepatobiliary51 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypersensitivity50 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Anemia36 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other neurologic47 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Constitutional17 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hemorrhage40 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other Cardiac48 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Rhinitis50 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Edema (limb)48 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Metabolic30 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Pain33 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.GI28 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Leukopenia48 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypertension43 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Nausea44 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Dermatologic47 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neutropenia50 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Infection47 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Thrombocytopenia46 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypotension50 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Ocular/visual49 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neurosensory48 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Vomiting46 Participants
Treatment (Bevacizumab)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Musculoskeletal48 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Leukopenia4 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other Cardiac3 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Nausea6 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Metabolic16 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Constitutional23 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Dermatologic5 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Ocular/visual3 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Musculoskeletal1 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Edema (limb)3 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Infection0 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Pain11 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neurosensory4 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hepatobiliary0 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypersensitivity1 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hemorrhage9 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neutropenia2 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Rhinitis1 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other neurologic4 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.GI21 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypertension2 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Anemia9 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Vomiting4 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypotension1 Participants
Grade 1 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Thrombocytopenia6 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypotension0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neurosensory0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Anemia6 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other neurologic0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Ocular/visual0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Pain4 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypersensitivity1 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Rhinitis1 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypertension3 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other Cardiac1 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Thrombocytopenia0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Constitutional10 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Dermatologic0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Nausea2 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Vomiting2 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.GI2 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hemorrhage1 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neutropenia0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hepatobiliary0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Infection5 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Edema (limb)0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Leukopenia0 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Metabolic3 Participants
Grade 2 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Musculoskeletal0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neutropenia0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Pain4 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Rhinitis0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypersensitivity0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Infection0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Metabolic1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hemorrhage1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypotension1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Ocular/visual0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neurosensory0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Edema (limb)1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.GI1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Thrombocytopenia0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Leukopenia0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Constitutional2 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Musculoskeletal3 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Dermatologic0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypertension4 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other neurologic1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hepatobiliary1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other Cardiac0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Anemia1 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Nausea0 Participants
Grade 3 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Vomiting0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Nausea0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypertension0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other neurologic0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Vomiting0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Rhinitis0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Musculoskeletal0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.GI0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Leukopenia0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypersensitivity0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hemorrhage1 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Metabolic2 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Pain0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hepatobiliary0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Anemia0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neurosensory0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Infection0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neutropenia0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Ocular/visual0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Edema (limb)0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Constitutional0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Dermatologic0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Thrombocytopenia0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other Cardiac0 Participants
Grade 4 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypotension0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Pain0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Leukopenia0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Thrombocytopenia0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neutropenia0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Anemia0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypersensitivity0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Rhinitis0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypertension0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hypotension0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other Cardiac0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Constitutional0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Dermatologic0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Nausea0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Vomiting0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.GI0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hemorrhage0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Hepatobiliary0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Infection0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Edema (limb)0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Metabolic0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Musculoskeletal0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Neurosensory0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Other neurologic0 Participants
Grade 5 (CTCAE v 3.0)Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.Ocular/visual0 Participants
Primary

Progression-free Survival Greater Than 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.

Time frame: 6 months

Population: Total number of eligible and evaluable participants

ArmMeasureGroupValue (NUMBER)
Treatment (Bevacizumab)Progression-free Survival Greater Than 6 MonthsNo31 participants
Treatment (Bevacizumab)Progression-free Survival Greater Than 6 MonthsYes21 participants
Secondary

Histologic Grade

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

Time frame: Baseline

Population: Eligible and treated patients

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Treatment (Bevacizumab)Histologic GradeGrade 13 Participants
Treatment (Bevacizumab)Histologic GradeGrade 212 Participants
Treatment (Bevacizumab)Histologic GradeGrade 337 Participants
Secondary

Initial Performance Status

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

Population: Eligible and treated patients

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Treatment (Bevacizumab)Initial Performance StatusPerformance Status 034 Participants
Treatment (Bevacizumab)Initial Performance StatusPerformance Status 117 Participants
Treatment (Bevacizumab)Initial Performance StatusPerformance Status 21 Participants
Secondary

Overall Survival

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.

Population: Eligible and treated patients.

ArmMeasureValue (MEDIAN)
Treatment (Bevacizumab)Overall Survival10.55 months
Secondary

Progression-free Survival

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.

Population: Eligible and treated patients.

ArmMeasureValue (MEDIAN)
Treatment (Bevacizumab)Progression-free Survival4.17 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026