Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer
|ClinicalTrials.gov Identifier: NCT02112552|
Recruitment Status : Unknown
Verified February 2015 by Merieme Klobocista, Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was: Recruiting
First Posted : April 14, 2014
Last Update Posted : February 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Serous Adenocarcinoma Stage IIIA Uterine Corpus Cancer Stage IIIB Uterine Corpus Cancer Stage IIIC1 Uterine Corpus Cancer Stage IIIC2 Uterine Corpus Cancer Stage IVA Uterine Corpus Cancer Stage IVB Uterine Corpus Cancer||Drug: Paclitaxel Drug: Carboplatin Radiation: 3-Dimensional Conformal Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Other: Quality-of-Life Assessment Other: Laboratory Biomarker Analysis||Phase 2|
I. To evaluate the toxicity (as defined by National Cancer Institute [NCI] Common Toxicity Criteria version [v.] 4.0) of weekly intravenous (IV) paclitaxel with intraperitoneal (IP) carboplatin chemotherapy given every third week, followed by radiation therapy (RT) in patients with advanced stage uterine serous cancer (USC).
II. To determine the feasibility of this regimen in women with advanced stage USC.
I. To assess the frequency and the reasons for early discontinuation of the study treatments.
II. To describe patient-reported quality of life parameters at specified time points during the study using validated questionnaires: European Organization for Research and the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-ovarian cancer module (OV)28.
I. To define patterns of recurrence (e.g. local versus distant) and progression-free survival in patients with advanced and recurrent USC treated with dose dense IV paclitaxel and IP carboplatin therapy.
II. To correlate surrogate endpoint biomarkers that is performed in standard histology processing (estrogen receptor and progesterone receptor status as well as human epidermal growth factor 2 [Her2/neu] status) with progression-free survival and prognosis.
III. To assess the potential late effects of combined intraperitoneal chemotherapy and radiotherapy on the gastrointestinal, genitoureteral, bone marrow and other body systems beginning at 6 months post treatment completion during routine office visits.
CHEMOTHERAPY: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 and carboplatin intraperitoneally (IP) on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3-dimensional (3D) conformal or intensity-modulated radiation therapy (IMRT) 5 days a week for 5 weeks (weeks 19-23).
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter for up to 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||June 2016|
Experimental: Treatment (paclitaxel, carboplatin, radiotherapy)
CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity.
RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).
Other Names:Drug: Carboplatin
Given IPRadiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D conformal radiation therapy
Other Names:Radiation: Intensity-Modulated Radiation Therapy
Other Names:Other: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentOther: Laboratory Biomarker Analysis
- Degree of tolerability, estimated by the proportion of participants who complete 6 treatment cycles of IP carboplatin [ Time Frame: Up to 18 weeks ]At the end of the study, the proportion of patients who tolerated the therapy will be estimated, along with corresponding 95% confidence intervals. Reasons for discontinuation of therapy will be categorized and summarized by computing frequencies.
- Progression-free survival [ Time Frame: The duration of time from start of treatment to time of progression, or death, whichever happens first, assessed at 1 year ]The proportion of responders at one year will be estimated with the Kaplan-Meier method. Surrogate endpoint biomarkers including estrogen, progesterone, and Her2/neu receptor status will be correlated with progression-free survival using the Cox Proportional Hazards model, provided the availability of a sufficient number of events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112552
|United States, New York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Merieme Klobocista 718-405-8082 email@example.com|
|Principal Investigator: Merieme Klobocista|
|Principal Investigator:||Merieme Klobocista||Albert Einstein College of Medicine, Inc.|