Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Adenocarcinoma

Uterine Neoplasms

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma of the Appendix

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

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).

3-Dimensional Conformal Radiation Therapy

Intensity-Modulated Radiation Therapy

Quality-of-Life Assessment

Laboratory Biomarker Analysis

Marina Frimer, MD

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.

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.

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

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.

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.

National Cancer Institute (NCI)

Albert Einstein College of Medicine

4 participants were consented but only 3 participants were enrolled into the study. One participants screen failed shortly after consent due to the onset of and adverse event. Baseline demographics provided for all 4 participants.

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).

Paclitaxel: Given IV

Carboplatin: Given IP

3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy

Intensity-Modulated Radiation Therapy: Undergo IMRT

Quality-of-Life Assessment: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Treatment (Paclitaxel, Carboplatin, Radiotherapy)

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Jessica Atrio, Professor, Department of Obstetrics & Gynecology and Women's Health

Data was not collected/aggregated and therefore not analyzed for Degree of Tolerability

Degree of Tolerability, Estimated by the Proportion of Participants Who Complete 6 Treatment Cycles of IP Carboplatin

Data was not collected/aggregated and therefore not analyzed for Progression Free Survival

Progression-free Survival

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).

Paclitaxel: Given IV

Carboplatin: Given Intraperitoneal (IP)

3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy

Intensity-Modulated Radiation Therapy: Undergo IMRT

Quality-of-Life Assessment: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Spots Global Cancer Trial Database for stage iiic1 uterine corpus cancer