A Phase II Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma of Soft Tissue
University of Colorado, Denver
Summary
The overall goal of this Phase 2 study is to determine the efficacy of a lower dose weekly schedule of doxorubicin in patients with unresectable leiomyosarcomas aged 65-100 years old. While doxorubicin is the standard of care therapy for sarcomas not removable by surgery, older or more frail patients may struggle to tolerate side effects of the treatment including immune cell suppression. Previous studies have suggested that similar anti-tumor activity can be obtained using a lower dose, weekly administration schedule of doxorubicin. In this study, the investigators will determine progression-free survival rate at 12 weeks, with secondary endpoints including quality of life and adverse events in this population. Importantly, doxorubicin can also induce immune stimulatory effects when administered at lower doses, based on animal data. Thus, correlative samples including blood and tumor biopsies will also explore the effects of immune cells and foreignness of the tumor prior to and during treatment in study patients.
Description
The study is an open-label, single-arm, investigator-initiated Phase 2 trial enrolling up to 30 patients to obtain 20 evaluable patients with advanced/metastatic leiomyosarcomas. The study will utilize a time-to-event Bayesian optimal Phase 2 design. The design includes one interim futility look after 10 patients are evaluable for progression-free survival rate at 12 weeks. The outcomes will be compared to historical PFS 12 week rate calculated as the mean from two large randomized Phase 3 studies. The treatment will be deemed promising if the number of patients who are stable at 12 weeks is 6…
Eligibility
- Age range
- 65–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be male or female aged 65-100 years at the time of signing informed consent. 4. Have a histological diagnosis of advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery, for which treatment with weekly doxorubicin is deemed appropriate by the investigator. 5. Have measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Soli…
Interventions
- DrugDoxorubicin
Doxorubicin is an antibiotic derived from the Streptomyces peucetius bacterium. It has widespread use as a chemotherapeutic agent since the 1960s. Doxorubicin is part of the anthracycline group of chemotherapeutic agents. Doxorubicin may be used to treat soft tissue and bone sarcomas and cancers of the breast, ovary, bladder, and thyroid. It is also used to treat acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, and small cell lung cancer.
Location
- University Of Colorado HospitalAurora, Colorado