Trial · NCT00025233
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
NCT00025233, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix. Trials, record NCT00025233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00025233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
- NCT number
- NCT00025233
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer
- Interventions
- bevacizumab, laboratory biomarker analysis
- First posted
- 2003-01-27
- Last updated
- 2019-07-24
- Results first posted
- 2015-06-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Greater Than 6 Months | Every other 3-week treatment cycle for 6 months | Whether or not the patient survived progression-free for at least 6 months. |
| Primary | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Every cycle and 30 days after the end of treatment. (average 5 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. |
| Secondary | Tumor Response | Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months) | 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. |
| Secondary | Overall Survival | From study entry to death or last contact, up to 5 years. | The observed length of life from entry into the study to death or the date of last contact. |
| Secondary | Duration of Progression-free Survival | 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 | 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. |
| Secondary | 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. |
| Secondary | Age at Enrollment | Baseline |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Greater Than 6 Months | Every other 3-week treatment cycle for 6 months | Eligible and Treated Patients | percentage of participants | NUMBER |
| PRIMARY | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Every cycle and 30 days after the end of treatment. (average 5 months) | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tumor Response | Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months) | Eligible and treated patients. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From study entry to death or last contact, up to 5 years. | Eligible and treated patients. | months | MEDIAN |
| SECONDARY | Duration of Progression-free Survival | 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 | Eligible and treated patients | months | MEDIAN |
| SECONDARY | Performance Status | Baseline | Eligible and treated patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Age at Enrollment | Baseline | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Greater Than 6 Months | Bevacizumab | 23.9 | 90% Confidence Interval 14.0 to 36.5 | percentage of participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 0 | Leukopenia | 39 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 1 (CTCAE v 2.0) | Leukopenia | 3 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 2 (CTCAE v 2.0) | Leukopenia | 3 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 3 (CTCAE v 2.0) | Leukopenia | 1 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 4 (CTCAE v 2.0) | Leukopenia | 0 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 5 (CTCAE v 2.0) | Leukopenia | 0 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 0 | Thrombocytopenia | 43 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 1 (CTCAE v 2.0) | Thrombocytopenia | 3 | Participants | |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Grade 2 (CTCAE v 2.0) | Thrombocytopenia | 0 | Participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab | 50 | |
| Overall Study | COMPLETED | Bevacizumab | 46 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 4 |
Source ClinicalTrials.gov
Adverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic Rhinitis | Immune system disorders | Bevacizumab | 5 | 46 | |
| other | Allergic Reaction | Immune system disorders | Bevacizumab | 1 | 46 | |
| other | Inner Ear/Hearing | Ear and labyrinth disorders | Bevacizumab | 2 | 46 | |
| other | Middle Ear/Hearing | Ear and labyrinth disorders | Bevacizumab | 2 | 46 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab | 5 | 46 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab | 5 | 46 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bevacizumab | 1 | 46 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab | 10 | 46 | |
| other | Transfusion Prbc's | Blood and lymphatic system disorders | Bevacizumab | 12 | 46 | |
| other | Anemia | Blood and lymphatic system disorders | Bevacizumab | 33 | 46 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | ||
| Total, other adverse events | Bevacizumab | 46 | 46 |
| Total, serious adverse events | Bevacizumab | 27 | 46 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00025233
GET https://conductscience.org/api/trials/v1/NCT00025233/results?page=2