Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer
M.D. Anderson Cancer Center
Summary
To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.
Description
Primary Objectives: * To identify dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of the combination of paclitaxel/bevacizumab/lurbinectedin in women with platinum resistant ovarian cancer. * To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab/lurbinectedin. Secondary Objectives: * To assess objective response (OR) and duration of response (DOR). * To assess clinical benefit rate (CBR), defined as proportion of patients with OR or stable disease (SD) \> 4 months. * To estimate progressi…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Inclusion criteria will be assessed within 28 days of starting study treatment: 1. Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines. 2. Age ≥ 18 years at time of study entry 3. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 4. Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory\* or platinum resistant\*\* disease are allowed. Pri…
Interventions
- DrugPaclitaxel
Given by (IV) vein
- DrugBevacizumab
Given by (IV) vein
- DrugLurbinectedin
Given by (IV) vein
Location
- M D Anderson Cancer CenterHouston, Texas