nab-Paclitaxel + Gemcitabine for Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if the combination of nab-paclitaxel and gemcitabine can stop tumors from growing in patients whose cancer has come back or did not respond to previous treatments. The study also checks if this combination is safe and tolerable. Nab-paclitaxel (Abraxane) is an albumin-bound paclitaxel that has shown clinical activity in advanced breast and lung cancer and has been tested in combination with gemcitabine for advanced pancreatic cancer, improving response rates and survival.
Will I have to stop taking my current medications?
The trial requires that you avoid certain medications that affect the metabolism of paclitaxel, such as ketoconazole, erythromycin, and rifampicin, among others. If you are taking any of these, you would need to stop them to participate in the trial.
Is the combination of nab-Paclitaxel and Gemcitabine generally safe for humans?
The combination of nab-Paclitaxel and Gemcitabine is used as a standard treatment for pancreatic cancer and has been studied for safety in various conditions, including pancreatic cancer and sarcomas. It is generally considered safe, but specific safety data for pediatric sarcoma patients is not yet reported.12345
How is the drug nab-Paclitaxel + Gemcitabine unique for treating sarcoma?
The combination of nab-Paclitaxel and Gemcitabine is unique for treating sarcoma because it uses a nanotechnology-based drug (nab-Paclitaxel) that improves drug delivery and effectiveness, showing promising results in preclinical models and offering a potential new option for patients with relapsed or hard-to-treat sarcomas.12367
What data supports the effectiveness of the drug combination nab-Paclitaxel and Gemcitabine for treating sarcoma?
Who Is on the Research Team?
Javier Oesterheld, M.D.
Principal Investigator
Carolinas Medical Center, Levine Cancer Institute
Are You a Good Fit for This Trial?
This trial is for young people aged 3 to 30 with certain types of sarcoma, including osteosarcoma and Ewing sarcoma, that have come back or didn't respond to initial treatments. They must have measurable disease, be in good physical condition with a Karnofsky score ≥60, and not pregnant. Participants should not have had prior treatment with the study drugs or recent chemotherapy and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28-day cycle, for up to 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- nab-Paclitaxel
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
National Pediatric Cancer Foundation
Collaborator