Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Carboplatin
  • Drug: Cisplatin
  • Radiation: Internal Radiation Therapy
  • Drug: Paclitaxel
  • Other: Quality-of-Life Assessment
  • Radiation: Radiation Therapy

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting