NCT02112552

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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 months post treatment completion during routine office visits. OUTLINE: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given IV
DRUG	Carboplatin	Given IP
RADIATION	3-Dimensional Conformal Radiation Therapy	Undergo 3D conformal radiation therapy
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2014-04-10
• Primary completion: 2016-08-01
• Completion: 2017-12-01
• First posted: 2014-04-14
• Last updated: 2023-08-29
• Results posted: 2023-08-29

Locations

1 site across 1 country: United States