Clinical Trial: Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma

Brief Summary: This pilot, phase II trial studies the side effects and how well paclitaxel given into the vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping them from spreading. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may be an effective treatment for uterine cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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 m
Sponsor: Albert Einstein College of Medicine, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: Degree of tolerability, estimated by the proportion of participants who complete 6 treatment cycles of IP carboplatin [ Time Frame: Up to 26 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.


Current Secondary Outcome: 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.


Original Secondary Outcome: 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.


Information By: Albert Einstein College of Medicine, Inc.

Dates:
Date Received: April 10, 2014
Date Started: May 2013
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015