Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas
National Cancer Institute (NCI)
Summary
This phase I/II trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.
Description
PRIMARY OBJECTIVES: I. The primary objective of the phase 1 part of this trial is to define the schedule of sequential abemaciclib and gemcitabine and recommended phase 2 dose (RP2D) of retinoblastoma positive (Rb\[+ve\]) sarcomas. II. The primary objective of the phase 2 part of the trial is to define the progression-free survival (PFS) of sequential abemaciclib followed by gemcitabine at RP2D compared to the standard of care gemcitabine and docetaxel in advanced Rb(+ve) leiomyosarcomas and dedifferentiated liposarcomas. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Phase 1: Patients must have advanced/metastatic histologically confirmed soft tissue sarcoma and have received at least one prior standard systemic therapy (prior gemcitabine is allowed) * Phase 2: Patients must have advanced/metastatic pathologically confirmed leiomyosarcoma or dedifferentiated liposarcoma for which gemcitabine and docetaxel is considered standard-of-care, patients may be systemic-treatment naïve. Prior gemcitabine is not allowed * Patients must have presence of measurable/assessable tumor * Patients must have intact Rb gene expression in the baseline t…
Interventions
- DrugAbemaciclib
Given PO
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- DrugDocetaxel
Given IV
- DrugGemcitabine
Given IV
Location
- M D Anderson Cancer CenterHouston, Texas