Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Epithelial Ovarian Cancer

Treatments

Drug: carboplatin

Drug: paclitaxel

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00490711

4720

B9E-MC-S205

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.

Enrollment

7 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically verified epithelial ovarian cancer
FIGO stage III-IV
Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment.
Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm.

Exclusion criteria

Ovarian tumors with low malignant potential (borderline tumors)
Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors)
Time between definitive surgery and enrollment into the study is greater than 6 weeks
Patients who have received previous chemotherapy or radiotherapy