Trial · NCT00296816
TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary
NCT00296816, Phase 2, Completed, Sanofi; results first posted 2012-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary. Trials, record NCT00296816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00296816
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary
- NCT number
- NCT00296816
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 132 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Ovarian Cancer
- Interventions
- Bevacizumab (Avastin®), Docetaxel (Taxotere®), Oxaliplatin (Eloxatin®)
- First posted
- 2006-02-27
- Last updated
- 2012-08-23
- Results first posted
- 2012-08-23
- Limitations and caveats
One site closed prematurely during the study. Every effort was made to collect, at minimum, any outstanding safety data for the participants at this site. As a result, participants from this site were included only in the safety analysis.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Twelve-month Progression-free Survival (PFS) Rate in Participants | up to 12 months following treatment initiation | Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: * appearance of a new lesion * symptomatic deterioration * progression of target or nontarget lesions * death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS. |
| Secondary | Twenty Four-month Progression-free Survival (PFS) Rate in Participants | up to 24 months following treatment initiation | Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: * appearance of a new lesion * symptomatic deterioration * progression of target or nontarget lesions * death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS. |
| Secondary | Median Time to Progression-free Survival (PFS) | up to approximately 1300 days following treatment initiation | Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Time of PFS was censored * on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery), * at Day 1, for living participants with no post-baseline tumor assessments. Median PFS was estimated from a Kaplan-Meier curve. |
| Secondary | Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | up to 12 months following treatment initiation | Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which: * Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions * Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks. |
| Secondary | Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline | up to 12 months following treatment initiation | Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died. Disease progression included the following: * the appearance of a new lesion * symptomatic deterioration * progression of non-target lesions * a predefined serum CA 125 increase. RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS. |
| Secondary | Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline | up to approximately 1500 days following treatment initiation | The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first. Participants were * censored on the last available CA 125 biomarker blood draw date if * left the study prior to disease progression or death * they received off-study anti-tumor medication * underwent debulking surgery * censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw. |
| Secondary | CA-125 Response Rate | up to 12 months after treatment initiation | A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days. The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup. |
| Secondary | Overall Survival Rate | up to up to approximately 1700 days after treatment initiation | Survival was the observed length of life from entry into the study to death or the date of last contact. The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here. |
| Secondary | Median Overall Survival Time | up to approximately 1700 days after treatment initiation | Survival was the observed length of life from entry into the study to death or the date of last contact. The median overall survival time was estimated using Kaplan-Meier Curve. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Twelve-month Progression-free Survival (PFS) Rate in Participants | up to 12 months following treatment initiation | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | percentage of participants | NUMBER |
| SECONDARY | Twenty Four-month Progression-free Survival (PFS) Rate in Participants | up to 24 months following treatment initiation | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Progression-free Survival (PFS) | up to approximately 1300 days following treatment initiation | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | days | MEDIAN |
| SECONDARY | Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | up to 12 months following treatment initiation | Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | participants | NUMBER |
| SECONDARY | Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline | up to 12 months following treatment initiation | All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline | up to approximately 1500 days following treatment initiation | All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures. | days | MEDIAN |
| SECONDARY | CA-125 Response Rate | up to 12 months after treatment initiation | All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival Rate | up to up to approximately 1700 days after treatment initiation | Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | percentage of participants | NUMBER |
| SECONDARY | Median Overall Survival Time | up to approximately 1700 days after treatment initiation | Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Twelve-month Progression-free Survival (PFS) Rate in Participants | Oxaliplatin/Docetaxel/Bevacizumab | 65.7 | 95% Confidence Interval 53.4 to 76.7 | percentage of participants | |
| Twenty Four-month Progression-free Survival (PFS) Rate in Participants | Oxaliplatin/Docetaxel/Bevacizumab | 34.3 | 95% Confidence Interval 23.3 to 46.6 | percentage of participants | |
| Median Time to Progression-free Survival (PFS) | Oxaliplatin/Docetaxel/Bevacizumab | 495 | 95% Confidence Interval 384 to 596 | days | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Unconfirmed response (CR+PR) | 51 | participants | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Unconfirmed complete response (CR) | 23 | participants | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Unconfirmed partial response (PR) | 28 | participants | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Unconfirmed progressive disease (PD) | 5 | participants | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Confirmed response (CR+PR) | 41 | participants | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Confirmed complete response (CR) | 21 | participants | |
| Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) | Oxaliplatin/Docetaxel/Bevacizumab | Confirmed partial response (PR) | 20 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxaliplatin/Docetaxel/Bevacizumab | 132 | |
| Overall Study | COMPLETED | Oxaliplatin/Docetaxel/Bevacizumab | 58 | |
| Overall Study | NOT COMPLETED | Oxaliplatin/Docetaxel/Bevacizumab | 74 |
Source ClinicalTrials.gov
Adverse events122
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 | Neutropenia | Blood and lymphatic system disorders | Oxaliplatin/Docetaxel/Bevacizumab | 59 | 132 | |
| other | Leukopenia | Blood and lymphatic system disorders | Oxaliplatin/Docetaxel/Bevacizumab | 31 | 132 | |
| other | Anaemia | Blood and lymphatic system disorders | Oxaliplatin/Docetaxel/Bevacizumab | 18 | 132 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Oxaliplatin/Docetaxel/Bevacizumab | 13 | 132 | |
| other | Lacrimation increased | Eye disorders | Oxaliplatin/Docetaxel/Bevacizumab | 35 | 132 | |
| other | Vision blurred | Eye disorders | Oxaliplatin/Docetaxel/Bevacizumab | 10 | 132 | |
| other | Nausea | Gastrointestinal disorders | Oxaliplatin/Docetaxel/Bevacizumab | 85 | 132 | |
| other | Diarrhoea | Gastrointestinal disorders | Oxaliplatin/Docetaxel/Bevacizumab | 77 | 132 | |
| other | Constipation | Gastrointestinal disorders | Oxaliplatin/Docetaxel/Bevacizumab | 59 | 132 | |
| other | Vomiting | Gastrointestinal disorders | Oxaliplatin/Docetaxel/Bevacizumab | 42 | 132 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin/Docetaxel/Bevacizumab | ||
| Total, other adverse events | Oxaliplatin/Docetaxel/Bevacizumab | 130 | 132 |
| Total, serious adverse events | Oxaliplatin/Docetaxel/Bevacizumab | 33 | 132 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00296816
GET https://conductscience.org/api/trials/v1/NCT00296816/events?page=2