Efficacy Study of Weekly Taxotere and Topotecan for Recurrent Gynecologic (GYN) Cancers

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