Weekly Topotecan Therapy in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.

Detailed Description
-----------------
Patients with Stage IIIC and IV optimally-debulked ovarian cancer will be treated with 6 cycles (every 3 weeks) of carboplatin (AUC 5) and paclitaxel (175 mg/m2). Patients who demonstrate a complete clinical response to this regimen will then be treated with topotecan consolidation (4 mg/m2 weekly x 8 weeks for one cycle followed by a break in the 9th week) for a maximum of 3 cycles. Primary endpoints will be toxicity and the determination of the appropriate dose, schedule, and duration of topotecan for further consolidation trials.

Official Title
-----------------
A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a histopathologic diagnosis of epithelial ovarian cancer. Patients must have completed front-line chemotherapy and be clinically NED (CA 125 <35, negative CT scan, negative physical exam). Patients may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative). Patients must not have had other myelosuppressive therapy within four weeks of initiating topotecan therapy. Topotecan treatment must begin within 10 weeks following last cycle of initial chemotherapy. Patients may have had only one prior chemotherapy regimen. Exclusion Criteria: Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer. Patients who are pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topotecan|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy (Progression free survival) of weekly topotecan as consolidation therapy in ovarian cancer patients who are clinically NED or have microscopic disease only after first-line chemotherapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Cancer, Cancer of the Ovary