Clinical trial NCT00231855 (phase 2, status: completed)
Conditions: ovarian neoplasms, uterine neoplasms
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C57.4, D28.2
Drugs: topotecan and taxotere
SMILES: CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented recurrent endometrial adenocarcinoma, papillary serous
             (UPSC), or mixed mullerian tumor (MMT) for which a cure or substantial palliation is
             unlikely using surgery and/or radiotherapy. Patients must have measurable disease or
             disease felt to be reproducibly measurable on CT scan, chest x-ray and/or tumor marker
             elevations .

          -  Recurrent ovarian or primary peritoneal cancers as defined as either:

               1. Measurable disease either by physical examination or by imaging or

               2. Non-measurable evidence of disease such as any or all of the following standard
                  Rustin criteria:

                    1. Peritoneal implants <2 cm

                    2. Abnormal densities on computerized tomography (CT) scan and/or loculated
                       fluid collections

                    3. Elevated CA-125 (>100 U/mL on 2 measurements at least 1 week apart) and
                       disease- related symptoms.

          -  Patients with the following histologic ovarian or uterine epithelial cell types are
             eligible:

               -  Serous adenocarcinoma

               -  Endometrioid adenocarcinoma

               -  Mucinous adenocarcinoma

               -  Undifferentiated carcinoma

               -  Clear cell adenocarcinoma

               -  Mixed epithelial carcinoma

               -  Transitional cell

               -  Malignant Brenner's tumor

               -  Adenocarcinoma NOS

          -  Age ≥ 18 years.

          -  ECOG performance status of ≤ 2.

          -  Peripheral neuropathy must be ≤ grade 1

          -  Previously treated patients must have received no antineoplastic treatment for at
             least 4 weeks. Patients will not have received more than two previous chemotherapy
             regimens.

          -  In patients previously irradiated, the recurrent disease should be outside of the
             radiotherapy portal or have developed disease progression within the radiated field.

          -  No concurrent chemotherapy, radiotherapy, immunotherapy, or hormone therapy.

          -  Hepatic:

               -  Total bilirubin ≤ ULN

               -  AST and ALT and alkaline phosphatase must be within the range allowing for
                  eligibility.

          -  Patients must be alert, oriented, and have signed an informed consent in accordance
             with institutional policies and be aware of the investigational nature of the study.

          -  Women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter

        Exclusion Criteria:

          -  Patient has impairment of hepatic, renal or hematologic function as defined by the
             following baseline laboratory values:

               1. Serum creatinine clearance ≤ 50 ml/min

               2. Platelets <100,000/mm3

               3. Absolute neutrophil count (ANC) <1500/mm3

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

          -  History of chronic or active hepatitis

          -  Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes,
             unstable angina, myocardial infarction within 6 months, congestive heart failure,
             etc.)

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

          -  Patients with a history of severe hypersensitivity to Taxotere®, Topotecan®, or other
             drugs formulated with polysorbate 80.

          -  Women who are pregnant or breast-feeding