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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary aim of this study is:

• To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers.

The secondary aims of this study are:

• To evaluate the safety and tolerability of the combination therapy with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers.

• To determine the progression free survival and overall survival in women treated with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy and/or radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborators: GlaxoSmithKline; Sanofi
• Treatments: Docetaxel; Topotecan

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