None listed
Conditions
Brief summary
Platinum-based combinations are standard 2nd-line treatment for platinum-sensitive ovarian cancer. This randomized phase II study was conducted to evaluate the efficacy and safety of a carboplatin-based combination with pegylated LD versus the standard combination of carboplatin with paclitaxel in patients with ovarian cancer relapsing at least 6 months after 1st-line platinum-based therapy. It is hypothesised that the combination of carboplatin-pegylated LD will be at least as effective with a more favourable toxicity profile than the standard combination with paclitaxel.
Interventions
chemotherapy with Carboplatin plus pegylated Liposomal Doxorubicin (CLD): pegylated Liposomal Doxorubicin was administered as an intravenous infusion of 90 min at a dose of 45 mg/m2 followed by an intravenous infusion of 1 hour of Carboplatin at Area Under the Curve (AUC) 5, on day 1. Cycles were repeated every 28 days. Premedication included 20 mg dexamethasone, 4mg dyphenidramine, 150 mg ranitidine administered intravenously immediatelly prior to pegylated Liposomal Doxorubicin administratio
chemotherapy with Carboplatin plus pegylated Liposomal Doxorubicin (CLD): pegylated Liposomal Doxorubicin was administered as an intravenous infusion of 90 min at a dose of 45 mg/m2 followed by an intravenous infusion of 1 hour of Carboplatin at Area Under the Curve (AUC) 5, on day 1. Cycles were repeated every 28 days. Premedication included 20 mg dexamethasone, 4mg dyphenidramine, 150 mg ranitidine administered intravenously immediatelly prior to pegylated Liposomal Doxorubicin administration. The dose of carboplatin based on AUC was calculated by the estimated creatinine clearance using Calvert’s formula. Six cycles of chemotherapy were administered unless evidence of disease progression or unacceptable toxicity occurred.
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed