A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer

Conditions de participation

• Sexe:

  FEMALE

• Âges admissibles:

  18 and up

Critères de participation

Inclusion Criteria:

* Patients with pure serous endometrial carcinoma will be included. Other histotypes (endometrioid and clear cell) with abnormal/mutant-type p53 is acceptable.
* Local TP53 results must be available for Central review.
* Patients diagnosed with stage I, II tumors will be enrolled in the early stage cohort.
* Patients suitable for an optimal surgery.
* Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%).
* Life expectancy of greater than 3 months.
* Patients must have archival tissue available. If no tissue is available, tumor biopsy will be mandatory.
* Ability to understand and willing to sign a written informed consent document.
* Within 8 days of the proposed start of treatment, patients must have normal organ and marrow function.
* Women of child-bearing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.

Exclusion Criteria:

* Any other condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Mixed serous tumors without p53 aberration or with only subclonal p53 aberration
* Endometrial carcinosarcoma
* Patients being treated with radiotherapy within 4 weeks, or palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of starting study treatment.
* Patients who are receiving any other investigational agents.
* Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.
* Patients with evidence of fistula will be excluded.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
* Uncontrolled inter-current illness that would limit compliance with study requirements.
* Pregnant women are excluded.
* Known HIV-positive patients on antiretroviral therapy or active Hepatitis B or C are ineligible.
* Patients with a history of other malignancy ≤ 2 years prior to registration, with exceptions.