Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

• Status: Terminated
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x rays to kill tumor cells. 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, by stopping them from dividing or by stopping them from spreading. Giving radiation therapy with chemotherapy may kill more tumor cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:

• Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;

• Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);

• Any surgical stage II disease (II);

• Any surgical stage III disease (IIIA, IIIB, IIIC); and

• Any surgical stage IV disease with no residual macroscopic tumor

• Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of < 2

• Written voluntary informed consent

Exclusion Criteria:

• Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal

• Total serum bilirubin > 1.5 mg/dl

• History of chronic or active hepatitis

• Serum creatinine > 2.0 mg/dl

• Platelets < 100,000/mm^3

• Absolute neutrophil count (ANC) < 1500/mm^3

• Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)

• Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)

• Patient with any prior chemotherapy or radiotherapy for pelvic malignancy

• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry

• Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years