Conditions: Ovarian Cancer
Keywords: chemotherapy combination therapy targeted therapy second-line
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this study.

Detailed description:
On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day will be administered via continuous infusion for 9 days beginning on Day 1 of every 21 day cycle. Additionally, patients will receive erlotinib 150 mg daily Days 1-9 in a cycle of 21 days. Thereafter both drugs will be given as long as patient benefit continues. Treatment will be administered on an inpatient or outpatient basis, repeating administration on an every 3 week cycle.

A cycle will be one three-week course of the erlotinib-topotecan regimen (the cycle could be extended to 4 weeks if blood studies at 21 days result in treatment delay).

The dose of topotecan will be calculated as follows:

BSA (m\^2) X drug dose (mg/m\^2) = dose (mg)

Arms:
arm 1: Topotecan 0.4 mg/m\^2/day administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle; erlotinib 150 mg daily for 9 days every 21 days cycle. Both drugs will be given for a minimum of 2 cycles.

Interventions: intervention 1: Topotecan intervention 2: Erlotinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: