Gemcitabine in Ovarian Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: cisplatin; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191334

B9E-MW-S368

9340

Details and patient eligibility

About

The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG = 0-2
• Operated patients
• disease stage III-IV

Exclusion criteria

• No prior chemotherapy or radiation therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

A

Experimental group

Treatment:

Drug: gemcitabine

Drug: cisplatin