Endometrial CancerPhase 2NCT00513786
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
A Phase 2 study testing Carboplatin, Paclitaxel and bevacizumab in people with Endometrial Cancer, run by David O'Malley at 1 site in United States.
Trial summary
Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Carboplatin, Paclitaxel and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2007to 3 Jan 2017
- 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
- Advanced Stage Endometrial Cancer (Stage 3 or 4)
- Any Histology including clear cell, and serous papillary carcinomas
- surgery must have had hysterectomy and bilateral salpingo-oophorectomy
- chemotherapy initiated 12 weeks after surgery
- sign informed consent
- Adequate End-organ function
Show all 10Show fewer
- GOG (Gynecologic Oncology Group)Performance Status 0,1,2
- Patients must be 18 years or older
- Patients may have received radiation for the treatment of endometrial cancer.
- Patients may have measurable or non-measurable disease.
Who cannot join
- Patient with concomitant malignancy other than non-melanoma skin cancer
- Patients with prior malignancy who have been disease free for 5 years.
- Patients with serious uncontrolled infection, angina or serious peripheral neuropathy.
- Patients whose circumstances will not permit study completion or adequate follow up
- Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University-Division of Gyn Oncology
Columbus, Ohio, 43210
About this study
Official title: A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.
Read the detailed description
The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.
- Conditions
- Endometrial Cancer
- Being tested
- Carboplatin, Paclitaxel, bevacizumab
- Keywords
- Endometrial Cancer, Advanced Stage Endometrial Cancer, Stage 3 or 4 endometrial cancer, Cancer treatment, gyn cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Paraplatin, CBDCA
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
PaclitaxelDrug
Also called Onxol, Taxol
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumabDrug
Also called Avastin
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| carboplatin/paclitaxel with bevacizumab | Experimental | A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Patients With Progression Free Survival (PFS)
Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.
Measured: up to 57 months
Secondary outcomes (3)
To Estimate Overall Survival
Measured: up to 24 months
Number of Patients With Adverse Events as a Measure of Safety and Tolerability.
Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
Measured: up to 24 months
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study start1 Aug 2007
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
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 Endometrial CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- David O'Malley
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, David O'Malley, Ohio State University Comprehensive Cancer Center
- Investigators
- David O'Malley, MD, Principal investigator, The Ohio State University Division of Gyn Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513786
- Sponsor's protocol ID
- OSU-06133
- Other IDs
- NCI-2012-01229
- Status last verified
- Mar 2025
- First submitted
- 8 Aug 2007
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00513786
- Acronym / sponsor ID
- OSU-06133
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Advanced Stage Endometrial Cancer, Stage 3 or 4 endometrial cancer, Cancer treatment, gyn cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- David O'MalleyUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.
Detailed description
The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carboplatin/paclitaxel with bevacizumab | Experimental | Drug: Carboplatin, Drug: Paclitaxel, Drug: bevacizumabA regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Advanced Stage Endometrial Cancer (Stage 3 or 4)
- Any Histology including clear cell, and serous papillary carcinomas
- surgery must have had hysterectomy and bilateral salpingo-oophorectomy
- chemotherapy initiated 12 weeks after surgery
- sign informed consent
Key exclusion criteria (5 listed)
- Patient with concomitant malignancy other than non-melanoma skin cancer
- Patients with prior malignancy who have been disease free for 5 years.
- Patients with serious uncontrolled infection, angina or serious peripheral neuropathy.
- Patients whose circumstances will not permit study completion or adequate follow up
- Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.
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 |
|---|---|---|
| CarboplatinAlso: Paraplatin, CBDCAAUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles. | Drug | carboplatin/paclitaxel with bevacizumab |
| PaclitaxelAlso: Onxol, Taxol175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles. | Drug | carboplatin/paclitaxel with bevacizumab |
| bevacizumabAlso: Avastin15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles. | Drug | carboplatin/paclitaxel with bevacizumab |
Primary outcome
Evaluate Patients With Progression Free Survival (PFS)
Time frame: up to 57 months
Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.
3 secondary outcomes
To Estimate Overall Survival
Time frame: up to 24 months
Number of Patients With Adverse Events as a Measure of Safety and Tolerability.
Time frame: up to 24 months
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David O'Malley, MD principal investigator
The Ohio State University Division of Gyn Oncology
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 Carboplatin, Paclitaxel and bevacizumab in people with Endometrial Cancer, run by David O'Malley 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 10 inclusion and 5 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 28 Mar 2025. 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 28 Mar 2025). 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?
Evaluate Patients With Progression Free Survival (PFS) (time frame: up to 57 months). 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 28 Mar 2025.