Phase II trial of carboplatin and distearoylphosphatidylcholine pegylated liposomal doxorubicin (Lipo-Dox) in recurrent platinum-sensitive ovarian cancer following front-line therapy with paclitaxel and platinum.

Abstract

OBJECTIVE:

To evaluate the effectiveness and toxicity of distearoylphosphatidylcholine pegylated liposomal doxorubicin (DPLD) combined with carboplatin for the treatment of platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer.

METHODS:

A phase II study of carboplatin/DPLD treatment for platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer was initiated in July 2002. As of March 2008, a total of 32 patients were enrolled.

RESULTS:

Of the 32 patients, one achieved a complete response; 19 (59%) achieved a partial response. The overall objective response rate was 62% (95% confidence interval [CI], 45%-80%). The median progression-free survival and overall survival for all 32 patients was 9.1 months (95% CI, 6.4-10.4 months) and 27.9 months (95% CI, 13.9-38.6 months), respectively. Toxicity was tolerable. The most common grade 3 or 4 toxicities were anemia (n=3) and nausea/vomiting (n=3). Grade 3/4 leukopenia (n=2), grade 3/4 thrombocytopenia (n=2) and grade 4 hepatitis (n=1) occurred in five patients.

CONCLUSION:

Carboplatin/DPLD appears to be an effective regimen with low toxicity for treatment of patients with platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer.

• Authors: Sheng-Mou Hsiao, Chi-An Chen, Ho-Hsiung Lin, Chang-Yao Hsieh, Lin-Hung Wei
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 112 Issue 1 Pg. 35-9 (Jan 2009) ISSN: 1095-6859 [Electronic] United States
• PMID: 18977021 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Phosphatidylcholines
• liposomal doxorubicin
• Polyethylene Glycols
• Doxorubicin
• 1,2-distearoyllecithin
• Paclitaxel

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Disease-Free Survival
• Doxorubicin (administration & dosage, analogs & derivatives)
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Ovarian Neoplasms (drug therapy)
• Paclitaxel (administration & dosage)
• Phosphatidylcholines (administration & dosage)
• Polyethylene Glycols (administration & dosage)