Ovarian CancerPhase 2TEACONCT00296816
TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary
A Phase 2 study testing Bevacizumab (Avastin®), Docetaxel (Taxotere®) and Oxaliplatin (Eloxatin®) in people with Ovarian Cancer, run by Sanofi at 1 site in United States.
Trial summary
Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bevacizumab (Avastin®), Docetaxel (Taxotere®) and Oxaliplatin (Eloxatin®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18 years of age or older
- Participants with a histologic diagnosis of ovarian, primary peritoneal, or fallopian tube carcinoma, Stage Ib- IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease ( > 1 cm maximal diameter any remaining lesion) following initial surgery.
- Participants with the following histologic epithelial cell types are eligible: Serious adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Participant must have adequate bone marrow function
- Participant must have adequate renal function
- Participant must have adequate urine protein/creatinine reaction (UPC) of <1.0;
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- Participant must have adequate neurologic function
- Hepatic function: Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
- Blood Coagulation parameters: PT such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a participant is on stable dose of therapeutic Warfarin or low molecular weight heparin) and a PTT < 1.2 times the upper limit normal.
- Participants must be enrolled in the study prior to 50 days (every effort will be made for prior to 28 days) after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction.
- Participants with measurable and non-measurable disease are eligible. Participants with suboptimal disease are eligible. Participants may or may not have cancer-related symptoms.
- Participants who have met the pre-entry requirements specified including serologic measurement of CA-125 as a baseline for subsequent determination of response using Rustin criteria.
- Participants with a GOG Performance Status of 0, 1, or 2.
Who cannot join
- Participants with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible. Participants with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible.
- Participants who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the skin is permitted, provided that it was completed more than 5 years prior to enrollment, and the participant remains free of recurrent or metastatic disease.
- Participants who have received any prior anticancer chemotherapy or biologic therapy for any malignancy are excluded.
- Participants with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.
- Participants with any history of cancer, with the exception of inclusion criteria #2 and #3, and non-melanoma skin cancer, who are cancer free for the last 5 years, are excluded.
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- Participant with acute hepatitis or active infection that requires parenteral antibiotics.
- Participants with serious, non-healing wound, ulcer, or bone fracture. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
- Participants with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
- Participants with active bleeding or pathologic conditions that carry high risk of bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
- Participants with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
- Participants with clinically significant cardiovascular disease.
- Participants with clinically significant proteinuria. Urine protein should be screened by urinalysis. Participants discovered to have a urine protein: serum creatinine ratio greater than or equal to 1 should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1000 mg protein/24 hr to allow participation in the study.
- Participants with or with anticipation of invasive procedures.
- Participants with GOG Performance Grade of 3 or 4.
- Participants who are pregnant or nursing.
- Participants with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies and hypersensitivity to polysorbate 80 or hypersensitivity to any of the study drugs and its ingredients.
- Participants who participated in a study with any investigational product/device within the last 30 days.
- Any medical condition that in the judgment of the investigator would jeopardize any participant safety or the study drug evaluation for efficacy and safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).
Read the detailed description
Participants were
- administered study medication approximately 28 days after initial surgery for ovarian cancer
- received the study treatment regimen of up to one year unless there was disease progression, unacceptable toxicity, death, participant refusal, or treatment delay beyond the time frame permitted for each treatment
Participants were followed for survival for a minimum 3 years from the date of enrollment
- Conditions
- Ovarian Cancer
- Being tested
- Bevacizumab (Avastin®), Docetaxel (Taxotere®), Oxaliplatin (Eloxatin®)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin®)Drug
15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity
Docetaxel (Taxotere®)Drug
75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
Oxaliplatin (Eloxatin®)Drug
85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin/Docetaxel/Bevacizumab | Experimental | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery Receives: Drug: Bevacizumab (Avastin®); Drug: Docetaxel (Taxotere®); Drug: Oxaliplatin (Eloxatin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twelve-month Progression-free Survival (PFS) Rate in Participants
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.
Measured: up to 12 months following treatment initiation
Secondary outcomes (8)
Twenty Four-month Progression-free Survival (PFS) Rate in Participants
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.
Measured: up to 24 months following treatment initiation
Median Time to Progression-free Survival (PFS)
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.
Measured: up to approximately 1300 days following treatment initiation
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)
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.
Measured: up to 12 months following treatment initiation
Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline
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.
Measured: up to 12 months following treatment initiation
Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline
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.
Measured: up to approximately 1500 days following treatment initiation
CA-125 Response Rate
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.
Measured: up to 12 months after treatment initiation
Overall Survival Rate
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.
Measured: up to up to approximately 1700 days after treatment initiation
Median Overall Survival Time
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.
Measured: up to approximately 1700 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phyllis Diener, BS, MT (ASCP), Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296816
- Sponsor's protocol ID
- PM_L_0239
- Acronym
- TEACO
- Status last verified
- Aug 2011
- First submitted
- 23 Feb 2006
- Last updated
- 23 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
- ClinicalTrials.gov ID
- NCT00296816
- Acronym / sponsor ID
- TEACO / PM_L_0239
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).
Detailed description
Participants were
- administered study medication approximately 28 days after initial surgery for ovarian cancer
- received the study treatment regimen of up to one year unless there was disease progression, unacceptable toxicity, death, participant refusal, or treatment delay beyond the time frame permitted for each treatment
Participants were followed for survival for a minimum 3 years from the date of enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin/Docetaxel/Bevacizumab | Experimental | Drug: Bevacizumab (Avastin®), Drug: Docetaxel (Taxotere®), Drug: Oxaliplatin (Eloxatin®)Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Females 18 years of age or older
- Participants with a histologic diagnosis of ovarian, primary peritoneal, or fallopian tube carcinoma, Stage Ib- IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease ( > 1 cm maximal diameter any remaining lesion) following initial surgery.
- Participants with the following histologic epithelial cell types are eligible: Serious adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Participant must have adequate bone marrow function
- Participant must have adequate renal function
Key exclusion criteria (19 listed)
- Participants with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible. Participants with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible.
- Participants who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the skin is permitted, provided that it was completed more than 5 years prior to enrollment, and the participant remains free of recurrent or metastatic disease.
- Participants who have received any prior anticancer chemotherapy or biologic therapy for any malignancy are excluded.
- Participants with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab (Avastin®)15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity | Drug | Oxaliplatin/Docetaxel/Bevacizumab |
| Docetaxel (Taxotere®)75 mg/m^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity | Drug | Oxaliplatin/Docetaxel/Bevacizumab |
| Oxaliplatin (Eloxatin®)85 mg/m^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity | Drug | Oxaliplatin/Docetaxel/Bevacizumab |
Primary outcome
Twelve-month Progression-free Survival (PFS) Rate in Participants
Time frame: 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.
8 secondary outcomes
Twenty Four-month Progression-free Survival (PFS) Rate in Participants
Time frame: up to 24 months following treatment initiation
Median Time to Progression-free Survival (PFS)
Time frame: up to approximately 1300 days following treatment initiation
Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: up to 12 months following treatment initiation
Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline
Time frame: up to 12 months following treatment initiation
Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline
Time frame: up to approximately 1500 days following treatment initiation
CA-125 Response Rate
Time frame: up to 12 months after treatment initiation
Overall Survival Rate
Time frame: up to up to approximately 1700 days after treatment initiation
Median Overall Survival Time
Time frame: up to approximately 1700 days after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis Diener, BS, MT (ASCP) study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab (Avastin®), Docetaxel (Taxotere®) and Oxaliplatin (Eloxatin®) in people with Ovarian Cancer, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twelve-month Progression-free Survival (PFS) Rate in Participants (time frame: up to 12 months following treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.