NCT00867503

Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer

Open Label Phase II Trial of Bendamustine Hydrochloride (HCL) in Women With Advanced Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study design is a non-randomized, open label, single center Phase II trial. Eligible patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease. Patients will be treated with bendamustine Hydrochloride 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2. 20 patients will be enrolled in the study. OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine hydrochloride, in women with platinum and taxane refractory ovarian cancer.

Detailed description

Bendamustine, a non-cross resistant cytotoxic, has potential to offer a new regimen for the treatment of ovarian cancer in women who are refractory to standard drug regimens. Non-cross resistance to platinum is critical for the development of effective salvage regimens in this platinum resistant population. In addition bendamustine's cytotoxic effects are thought to occur via several mechanistic pathways, apoptosis, DNA repair, DNA replication, DNA transcription. The study seeks to determine the efficacy and safety of bendamustine in women with advanced ovarian cancer.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Bendamustine HCL	bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-01-01
• Completion: 2013-04-01
• First posted: 2009-03-23
• Last updated: 2018-07-24
• Results posted: 2012-11-29

Locations

1 site across 1 country: United States