MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title: Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.

Clinical Trial Description

Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are frequent and 5-year survival is only 20%. Current therapies for second line treatment of recurrence in patients who have platinum refractory (who experienced progression of the disease during first line platinum based therapy) or platinum resistant (who experienced a recurrence of the disease within 6 months of completing platinum based therapy)ovarian cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast cancers, has shown some promise in early clinical trials for treating recurrent ovarian cancer.

Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14 every 21 days for up to 6 cycles, depending on response. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT00403429
• Study type: Interventional
• Source: National Cancer Institute, Naples
• Status: Completed
• Phase: Phase 2
• Start date: March 2006
• Completion date: July 2008