Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

• Status: Active, not recruiting
• Trial end date: 2024-07-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel; Succinylcholine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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