Weekly Topotecan Therapy in Patients With Ovarian Cancer

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00194935

Enrollment

Registered

2005-09-19

Start date

2003-02-28

Completion date

2006-08-31

Last updated

2006-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer, Cancer of the Ovary

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.

Interventions

DRUGTopotecan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026