Summary

for females ages 18 years and up (full criteria)
at San Diego, California and other locations
study started

Description

Summary

This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

Official Title

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Details

PRIMARY OBJECTIVES:

  1. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I or II serous (uterine papillary serous carcinoma [UPSC]) or clear cell endometrial carcinoma and positive cytology.

SECONDARY OBJECTIVES:

  1. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (i.e., increases survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with FIGO 2009 stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.

II. To compare the regimens with respect to acute and late adverse effects of therapy.

III. To determine the impact of patient-reported quality of life during and following treatment for up to 1 year with the two treatment regimens.

TERTIARY OBJECTIVES:

  1. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and whole blood specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) on days 1 and 29. Patients also undergo radiation therapy once daily (QD), 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Keywords

Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Stage IA Uterine Corpus Cancer Stage IB Uterine Corpus Cancer Stage II Uterine Corpus Cancer Stage IIIA Uterine Corpus Cancer Stage IIIB Uterine Corpus Cancer Stage IIIC Uterine Corpus Cancer Stage IVA Uterine Corpus Cancer Adenocarcinoma Uterine Neoplasms Cystadenocarcinoma, Serous Adenocarcinoma, Clear Cell Paclitaxel Albumin-Bound Paclitaxel Cisplatin Carboplatin Internal Radiation Therapy Quality-of-Life Assessment Radiation Therapy

Eligibility

You can join if…

Open to females ages 18 years and up

  • All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma
  • Surgical stage III disease includes those patients with positive adnexa,parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
  • Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
  • Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
  • Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional
  • Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
  • White blood cell (WBC) >= 3,000/mcl
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelet count >= 100,000/mcl
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN)
  • Alkaline phosphatase =< 2.5 times ULN
  • Bilirubin =< 1.5 times ULN
  • Creatinine =< institutional ULN
  • Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
  • Patients who have signed an approved informed consent and authorization permitting release of personal health information
  • Entry into the study is limited to no more than 8 weeks from the date of surgery

You CAN'T join if...

  • Patients with carcinosarcoma
  • Patients with recurrent endometrial cancer
  • Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension
  • Patients who have had pelvic or abdominal radiation therapy
  • Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
  • Patients with an estimated survival of less than three months
  • Patients with FIGO 2009 stage IVB endometrial cancer
  • Patients with parenchymal liver metastases
  • Patients who have received prior chemotherapy for endometrial cancer
  • Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment

Locations

  • University of California San Diego
    San Diego California 92103 United States
  • Gynecologic Oncology Associates-Newport Beach
    Newport Beach California 92663 United States
  • Saint Joseph Hospital - Orange
    Orange California 92868 United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • Long Beach Memorial Medical Center-Todd Cancer Institute
    Long Beach California 90806 United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles California 90027 United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank California 91505 United States
  • Olive View-University of California Los Angeles Medical Center
    Sylmar California 91342 United States
  • Cancer Center of Santa Barbara
    Santa Barbara California 93105 United States
  • Cancer and Blood Specialists-Henderson
    Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada - Henderson
    Henderson Nevada 89052 United States
  • Las Vegas Cancer Center-Henderson
    Henderson Nevada 89052 United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
    Las Vegas Nevada 89113 United States
  • Las Vegas Cancer Center-Medical Center
    Las Vegas Nevada 89148-2405 United States
  • 21st Century Oncology - Fort Apache
    Las Vegas Nevada 89148 United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas Nevada 89148 United States
  • Nevada Cancer Specialists-Fort Apache
    Las Vegas Nevada 89148 United States
  • 21st Century Oncology - Henderson
    Henderson Nevada 89074 United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson
    Henderson Nevada 89074 United States
  • Radiation Oncology Centers of Nevada Southeast
    Las Vegas Nevada 89119 United States
  • Comprehensive Cancer Centers of Nevada-Summerlin
    Las Vegas Nevada 89144 United States
  • Summerlin Hospital Medical Center
    Las Vegas Nevada 89144 United States
  • University Medical Center of Southern Nevada
    Las Vegas Nevada 89102 United States
  • 21st Century Oncology
    Las Vegas Nevada 89109 United States
  • Children's Specialty Center of Nevada II
    Las Vegas Nevada 89109 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
    Las Vegas Nevada 89109 United States
  • Comprehensive Cancer Centers of Nevada - Central Valley
    Las Vegas Nevada 89169 United States
  • Women's Cancer Center of Nevada
    Las Vegas Nevada 89169 United States
  • Cancer Therapy and Integrative Medicine
    Las Vegas Nevada 89121 United States
  • Cancer and Blood Specialists-Tenaya
    Las Vegas Nevada 89128 United States
  • Comprehensive Cancer Centers of Nevada - Northwest
    Las Vegas Nevada 89128 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
    Las Vegas Nevada 89128 United States
  • Cancer and Blood Specialists-Shadow
    Las Vegas Nevada 89106 United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas Nevada 89106 United States
  • Radiation Oncology Centers of Nevada Central
    Las Vegas Nevada 89106 United States
  • 21st Century Oncology - Vegas Tenaya
    Las Vegas Nevada 89182 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
    Las Vegas Nevada 89149 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Gynecologic Oncology Group
ID
NCT00942357
Phase
Phase 3
Study Type
Interventional
Last Updated
January 9, 2018