Endometrial CancerPhase 2NCT02744898
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
A Phase 2 study testing Carboplatin AUC and Abraxane in people with Endometrial Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of treatment with carboplatin and Abraxane in this patient population and determine the nature and degree of toxicities following treatment. 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 AUC and Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 Mar 2020
- 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
- Female patients must have high risk resected stage I disease (papillary serous histology, clear cell histology or carcinosarcoma), advanced stage (III or IV, all histologies) or recurrent endometrial cancer (all histologies). Patients do not need measurable disease and can enroll following surgery.
- Patients may not have received prior cytotoxic chemotherapy. However, nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed. Patients may have received prior radiation therapy (including whole pelvic or vaginal brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy must be discontinued at least 2 weeks prior to entry on this study.
- If patients underwent surgery, and chemotherapy is indicated after surgery either as adjuvant or to treat residual disease, study treatment should be initiated within 8 weeks of surgery.
- In patients who have received prior radiation, at least 4 weeks should have elapsed since the completion of radiation therapy involving the whole pelvis or over 50% of the spine. If vaginal brachytherapy is planned with chemotherapy, it should be done before or after completion of chemotherapy treatment.
- Poorly differentiated histology, uterine papillary serous carcinoma, clear cell carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic component is epithelial (versus sarcomatous).
- Patients may have synchronous endometrial and ovarian cancer primaries.
Show all 13Show fewer
- Patients must have a GOG performance status of 0, 1, or 2
- Patients must be at least 18 years of age.
- Patients must understand and willingly sign an approved informed consent, and authorization permitting release of personal health information.
- Patients must have adequate liver function: AST and ALT ≤ 2.5 X upper limit of normal (ULN), and bilirubin ≤ 1.5mg/dL.
- Patients must have adequate bone marrow function: platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample), hemoglobin > 9.0g/dl and ANC ≥ 1,500 cells/mm3.
- Patients must have adequate renal function: creatinine < 1.5 mg/dL is recommended; however, institutional norms are acceptable.
- Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE).
Who cannot join
- Other prior malignancies within 3 years, except non-melanoma skin cancers and synchronous ovarian primaries.
- Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial).
- Patients with concomitant medical illness such as serious uncontrolled infection, or uncontrolled angina, which in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient.
- Patients who are pregnant or breastfeeding.
- Patients with third degree or complete heart block are not eligible unless a pacemaker is in place. Patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators.
- Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a LVEF in the past 6 months is documented to be 50% or greater. Patients who have had a LVEF (performed for any reason) that is less than 50% in the past 6 months are ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Perlmutter Cancer Center
New York, New York, 10016
About this study
The purpose of this study is to evaluate the safety of treatment with carboplatin and Abraxane in this patient population and determine the nature and degree of toxicities following treatment. The single stage open label Phase II feasibility study is designed to estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with no more than two dose level reductions.
- Conditions
- Endometrial Cancer
- Being tested
- Carboplatin AUC, Abraxane
- Keywords
- uterus, gynecological, corpus uteri
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin AUCDrug
AbraxaneDrug
Also called Paclitaxel
100mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin AUC and Abraxane 100mg/m2 | Experimental | Not described Receives: Drug: Carboplatin AUC; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability Measured Completion of Dose Regimen
Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.
Measured: 24 months
Secondary outcomes (2)
Progression-Free Survival (PFS) at Month 24
PFS is defined as the time from first dosing to the first observation of disease progression or death due to any cause. PFS was estimated beyond the collected data using Kaplan Meier methods.
Measured: Up to Month 24
Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24
ORR is the number of patients whose best tumor response outcome by Month 24 is a Complete Response (CR) or Partial Response (PR), divided by the total number of evaluable patients.
Per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1.):
CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion17 Aug 2018
- Study completion1 Mar 2020
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.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Muggia, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744898
- Sponsor's protocol ID
- 15-01156
- Status last verified
- Aug 2023
- First submitted
- 15 Apr 2016
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
- ClinicalTrials.gov ID
- NCT02744898
- Acronym / sponsor ID
- 15-01156
- Conditions
- Endometrial Cancer
- Keywords
- uterus, gynecological, corpus uteri
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of treatment with carboplatin and Abraxane in this patient population and determine the nature and degree of toxicities following treatment. The single stage open label Phase II feasibility study is designed to estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with no more than two dose level reductions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin AUC and Abraxane 100mg/m2 | Experimental | Drug: Carboplatin AUC, Drug: Abraxane |
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)
- Female patients must have high risk resected stage I disease (papillary serous histology, clear cell histology or carcinosarcoma), advanced stage (III or IV, all histologies) or recurrent endometrial cancer (all histologies). Patients do not need measurable disease and can enroll following surgery.
- Patients may not have received prior cytotoxic chemotherapy. However, nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed. Patients may have received prior radiation therapy (including whole pelvic or vaginal brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy must be discontinued at least 2 weeks prior to entry on this study.
- If patients underwent surgery, and chemotherapy is indicated after surgery either as adjuvant or to treat residual disease, study treatment should be initiated within 8 weeks of surgery.
- In patients who have received prior radiation, at least 4 weeks should have elapsed since the completion of radiation therapy involving the whole pelvis or over 50% of the spine. If vaginal brachytherapy is planned with chemotherapy, it should be done before or after completion of chemotherapy treatment.
- Poorly differentiated histology, uterine papillary serous carcinoma, clear cell carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic component is epithelial (versus sarcomatous).
Key exclusion criteria (6 listed)
- Other prior malignancies within 3 years, except non-melanoma skin cancers and synchronous ovarian primaries.
- Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial).
- Patients with concomitant medical illness such as serious uncontrolled infection, or uncontrolled angina, which in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient.
- Patients who are pregnant or breastfeeding.
- Patients with third degree or complete heart block are not eligible unless a pacemaker is in place. Patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators.
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 |
|---|---|---|
| Carboplatin AUC | Drug | Carboplatin AUC and Abraxane 100mg/m2 |
| AbraxaneAlso: Paclitaxel100mg/m2 | Drug | Carboplatin AUC and Abraxane 100mg/m2 |
Primary outcome
Tolerability Measured Completion of Dose Regimen
Time frame: 24 months
Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.
2 secondary outcomes
Progression-Free Survival (PFS) at Month 24
Time frame: Up to Month 24
Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24
Time frame: Up to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Endometrial Cancer
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
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.
Franco Muggia, MD principal investigator
NYU Langone Health
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 AUC and Abraxane in people with Endometrial Cancer, run by NYU Langone Health 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 6 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 26 Sep 2023. 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 18 Mar 2020). 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?
Tolerability Measured Completion of Dose Regimen (time frame: 24 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 26 Sep 2023.