TriangleNCT00025233 · STUDY IN CONTEXT
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Whether or not the patient survived progression-free for at least 6 months.
The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
The observed length of life from entry into the study to death or the date of last contact.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- trial label
- Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0000
- source section id
- NCT00025233-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival Greater Than 6 Months
- endpoint definition
- Whether or not the patient survived progression-free for at least 6 months.
- time origin
- Every other 3-week treatment cycle for 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and Treated Patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- source section id
- NCT00025233-om-0001
- source outcome index
- 1
- endpoint
- Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
- endpoint definition
- The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
- time origin
- Every cycle and 30 days after the end of treatment. (average 5 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0002
- source section id
- NCT00025233-om-0002
- source outcome index
- 2
- endpoint
- Tumor Response
- endpoint definition
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
- time origin
- Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0003
- source section id
- NCT00025233-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival
- endpoint definition
- The observed length of life from entry into the study to death or the date of last contact.
- time origin
- From study entry to death or last contact, up to 5 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0004
- source section id
- NCT00025233-om-0004
- source outcome index
- 4
- endpoint
- Duration of Progression-free Survival
- endpoint definition
- 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 origin
- Every other 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0005
- source section id
- NCT00025233-om-0005
- source outcome index
- 5
- endpoint
- Performance Status
- endpoint definition
- 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 origin
- Baseline
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Bevacizumab
- regimen
- Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Grade 0
- regimen
- Number of patients who did not experience the specified AE.
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Grade 1 (CTCAE v 2.0)
- regimen
- Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Grade 2 (CTCAE v 2.0)
- regimen
- Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Grade 3 (CTCAE v 2.0)
- regimen
- Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Grade 4 (CTCAE v 2.0)
- regimen
- Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0001
- arm key
- OG005
- arm label
- Grade 5 (CTCAE v 2.0)
- regimen
- Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0001#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Bevacizumab
- regimen
- Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Bevacizumab
- regimen
- Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Bevacizumab
- regimen
- Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Bevacizumab
- regimen
- Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00025233-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-stage-ivb-recurrent-cf378e66
- nct id
- NCT00025233
- harm key
- EG000
- source section id
- NCT00025233-ae
- event group key
- EG000
- event group label
- Bevacizumab
- serious affected
- 27
- serious at risk
- 46
- other affected
- 46
- other at risk
- 46
- frequency threshold
- 0
- collection period
- All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice