A randomised phase II study comparing the activity and toxicity profiles of Carboplatin plus pegylated Liposomal Doxorubicin (CLD) versus Carboplatin plus Paclitaxel (CP) in potentially platinum sensitive ovarian cancer patients

Phase 2

Completed

• Conditions: platinum sensitive ovarian cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12609000436279
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 201

Inclusion Criteria

Women at least 18 years old, with histologically confirmed recurrent ovarian cancer (OC), 6 months or more after platinum-based chemotherapy, patients with bidimensionally measurable disease or only elevated serum tumour marker CA125 (more than twice the upper limit of normal), with Eastern Cooperative Oncology Group (ECOG) performance status 0–2 and life expectancy of at least 3 months were eligible. Adequate bone marrow, hepatic and renal functions were required.

Exclusion Criteria

Patients with a history of malignancy other than completely excised in situ carcinoma of the cervix or basal carcinoma of the skin, prior or recurrent central nervous system metastases, serious cardiac disease, other serious medical illness or inability to comply with the treatment plan and follow-up visits were excluded. Also patients with residual neurotoxicity from previous platinum and/or taxane chemotherapy were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified