Trial · NCT00803062
Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
NCT00803062, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2016-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer. Trials, record NCT00803062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00803062
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
- NCT number
- NCT00803062
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 452 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVB Cervical Cancer
- Interventions
- Bevacizumab, Cisplatin, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration, Topotecan Hydrochloride
- First posted
- 2008-12-05
- Last updated
- 2019-07-23
- Results first posted
- 2016-05-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From entry into the study to death or the date of last contact, assessed up to 5 years | The observed length of life from randomization into the study to death or the date of last contact. |
| Primary | Progression-free Survival | From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years) | Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate. |
| Primary | Tumor Response | Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years. | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR. |
| Primary | To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study. | From date of enrollment until 30 days after treatment completion | The number of patients on each arm who have Grade 3 AE or higher toxicity. |
| Other | Extent of Nicotine Dependence | Up to 5 years | Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death. |
| Other | Health-related Quality of Life | Up to 9 months after course 1 | Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score. |
| Other | Levels of Angiogenesis Markers in Plasma | Up to 5 years | Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response. |
| Other | Levels of Cell-free DNA in Plasma | Up to 5 years | Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response. |
| Other | Levels of Tumor Measures of Angiogenesis | Up to 5 years | Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response. |
| Other | Number of CTCs | Up to 5 years | Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From entry into the study to death or the date of last contact, assessed up to 5 years | All randomized patients. | months | MEDIAN |
| PRIMARY | Progression-free Survival | From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years) | All randomized patients. | months | MEDIAN |
| PRIMARY | Tumor Response | Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years. | All randomized patients. | percentage of participants | NUMBER |
| PRIMARY | To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study. | From date of enrollment until 30 days after treatment completion | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Extent of Nicotine Dependence | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Health-related Quality of Life | Up to 9 months after course 1 | |||
| OTHER_PRE_SPECIFIED | Levels of Angiogenesis Markers in Plasma | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Levels of Cell-free DNA in Plasma | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Levels of Tumor Measures of Angiogenesis | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Number of CTCs | Up to 5 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm I (Paclitaxel and Cisplatin) | 14.26 | 95% Confidence Interval 10.83 to 16.82 | months | |
| Overall Survival | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 17.51 | 95% Confidence Interval 13.96 to 22.93 | months | |
| Overall Survival | Arm III (Topotecan Hydrochloride and Paclitaxel) | 12.68 | 95% Confidence Interval 10.15 to 15.90 | months | |
| Overall Survival | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 16.20 | 95% Confidence Interval 12.71 to 18.96 | months | |
| Progression-free Survival | Arm I (Paclitaxel and Cisplatin) | 6.67 | 95% Confidence Interval 5.72 to 8.08 | months | |
| Progression-free Survival | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 9.63 | 95% Confidence Interval 7.16 to 12.68 | months | |
| Progression-free Survival | Arm III (Topotecan Hydrochloride and Paclitaxel) | 5.29 | 95% Confidence Interval 4.27 to 6.80 | months | |
| Progression-free Survival | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 7.36 | 95% Confidence Interval 5.75 to 9.56 | months | |
| Tumor Response | Arm I (Paclitaxel and Cisplatin) | 44.74 | 95% Confidence Interval 35.42 to 54.34 | percentage of participants | |
| Tumor Response | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 49.57 | 95% Confidence Interval 40.11 to 59.04 | percentage of participants |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Paclitaxel and Cisplatin) | 114 | |
| Overall Study | STARTED | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 115 | |
| Overall Study | STARTED | Arm III (Topotecan Hydrochloride and Paclitaxel) | 111 | |
| Overall Study | STARTED | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 112 | |
| Overall Study | COMPLETED | Arm I (Paclitaxel and Cisplatin) | 114 | |
| Overall Study | COMPLETED | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 115 | |
| Overall Study | COMPLETED | Arm III (Topotecan Hydrochloride and Paclitaxel) | 111 | |
| Overall Study | COMPLETED | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 112 | |
| Overall Study | NOT COMPLETED | Arm I (Paclitaxel and Cisplatin) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,752
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 Reaction/Hypersensitivity | Immune system disorders | Arm I (Paclitaxel and Cisplatin) | 19 | 112 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 20 | 111 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm III (Topotecan Hydrochloride and Paclitaxel) | 5 | 107 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 4 | 109 | |
| other | Rhinitis | Immune system disorders | Arm I (Paclitaxel and Cisplatin) | 6 | 112 | |
| other | Rhinitis | Immune system disorders | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 11 | 111 | |
| other | Rhinitis | Immune system disorders | Arm III (Topotecan Hydrochloride and Paclitaxel) | 5 | 107 | |
| other | Rhinitis | Immune system disorders | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 10 | 109 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Arm I (Paclitaxel and Cisplatin) | 1 | 112 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 1 | 111 |
1 to 10 of 1,752Source ClinicalTrials.gov
See all 1,752 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Paclitaxel and Cisplatin) | ||
| Total, all-cause mortality | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | ||
| Total, all-cause mortality | Arm III (Topotecan Hydrochloride and Paclitaxel) | ||
| Total, all-cause mortality | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | ||
| Total, other adverse events | Arm I (Paclitaxel and Cisplatin) | 112 | 112 |
| Total, other adverse events | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 111 | 111 |
| Total, other adverse events | Arm III (Topotecan Hydrochloride and Paclitaxel) | 107 | 107 |
| Total, other adverse events | Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab) | 107 | 109 |
| Total, serious adverse events | Arm I (Paclitaxel and Cisplatin) | 42 | 112 |
| Total, serious adverse events | Arm II (Paclitaxel, Cisplatin, Bevacizumab) | 53 | 111 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT00803062
GET https://conductscience.org/api/trials/v1/NCT00803062/results?page=2