Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
Condition: Recurrent Uterine Corpus Carcinoma; Stage IIIA Uterine Corpus Cancer AJCC v7; Stage IIIB Uterine Corpus Cancer AJCC v7; Stage IIIC Uterine Corpus Cancer AJCC v7; Stage IVA Uterine Corpus Cancer AJCC v7; Stage IVB Uterine Corpus Cancer AJCC v7
MeSH terms: Endometrial Neoplasms; Recurrence
Intervention: Carboplatin; Cisplatin; Doxorubicin Hydrochloride; Filgrastim; Laboratory Biomarker Analysis; Paclitaxel; Pegfilgrastim; Quality-of-Life Assessment
Intervention description: Given IV; Given IV; Given IV; Given SC; Correlative studies; Given IV; Given SC; Ancillary studies
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Doxorubicin; Liposomal doxorubicin; Albumin-Bound Paclitaxel; Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1381.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial compares how well two different combination chemotherapy
      regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and
      paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has
      come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride,
      cisplatin, 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. It is not yet known which combination chemotherapy regimen is more effective in
      treating endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have primary stage III or stage IV or recurrent endometrial carcinoma
             whose potential for cure by radiation therapy or surgery alone or in combination is
             very poor; pathological confirmation and estrogen receptor (ER)/progesterone receptor
             (PR) status of the primary tumor is mandatory; however, the results do not need to be
             available prior to registration

          -  Patients may not have received prior cytotoxic chemotherapy, including chemotherapy
             used for radiation sensitization; patients may have received prior radiation therapy,
             hormonal therapy, or therapy with biologic agents, but such therapies must be
             discontinued prior to entry on this study

          -  Patients in whom both radiation and chemotherapy is planned must receive radiation
             prior to entry on this study; at least four weeks should have elapsed since completion
             of radiation therapy (RT) involving the whole pelvis or over 50% of the spine

          -  Platelets >= 100,000/mcl

          -  Granulocytes (absolute neutrophil count [ANC]) >= 1,500/mcl

          -  Creatinine =< upper limit of normal (ULN) (Common Toxicity Criteria [CTC] grade 0) or
             calculated creatinine clearance (Jeliffe Formula) >= 60 ml/min

          -  Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x
             upper limits of normal

          -  Bilirubin =< institutional upper limits of normal

          -  Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

          -  Patients must have met the pre-entry requirements

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Patients with a concomitant malignancy other than non-melanoma skin cancer; with the
             exception of non-melanoma skin cancer, patients with a prior invasive malignancy who
             have been disease-free for < 5 years or who received prior chemotherapy for that
             malignancy

          -  Patients in whom pathological confirmation and estrogen receptor (ER)/progesterone
             receptor (PR) status of the tumor is not obtainable

          -  Patients for whom radiation therapy is planned during or after study chemotherapy
             prior to demonstrated progression

          -  Patients with concomitant medical illness such as serious uncontrolled infection,
             uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the
             treating physician, make the treatments prescribed on this study unreasonably
             hazardous for the patient

          -  Patients with third degree or complete heart block are not eligible unless a pacemaker
             is in place; patients on medications which alter cardiac conduction, such as
             digitalis, beta-blockers, or calcium channel blockers, or who have other conduction
             abnormalities or cardiac dysfunction may be placed on study at the discretion of the
             investigator

          -  Patients with history of myocardial infarct within 6 months before enrollment, New
             York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious
             for congestive heart failure are not eligible unless a left ventricular ejection
             fraction in the past 6 months is documented to be 50% or greater; patients who have
             had a left ventricular ejection fraction (LVEF) (performed for any reason) of less
             than 50% in the past 6 months are ineligible

          -  Patients whose circumstances will not permit study completion or adequate follow-up

          -  Patients who are sensitive to E. coli-derived drug preparations

          -  Patients with uterine carcinosarcoma or other non-epithelial uterine malignancies