Study on Nab-Paclitaxel and Gemcitabine for Treating Recurrent or Hard-to-Treat Sarcoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT02945800
This clinical trial is testing whether a combination of the drugs nab-paclitaxel and gemcitabine can help stop the growth of tumors in patients with certain types of sarcoma that have returned or are not responding to treatment. The study also aims to determine if this drug combination is safe and tolerable.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using nab-paclitaxel together with gemcitabine can prevent tumors from forming or growing in patients with certain types of sarcoma that have come back or are not responding to treatment. The study will also measure how long the disease stays stable during and after treatment. Researchers want to ensure that this combination of drugs is safe and can be tolerated by patients.
Eligibility Criteria
Inclusion Criteria
- Participants must be between 3 and 30 years old and have been diagnosed with osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or other soft tissue sarcomas.
- The cancer must have returned after initial treatment or not responded to initial treatment.
- Must have a tumor that can be measured by scans.
- The cancer must be one that does not have a known cure.
- Participants must not have had previous treatment with gemcitabine or nab-paclitaxel.
- Must have recovered from any side effects of previous treatments.
- Must not have received certain treatments within specific time frames before starting the study.
- Must have a performance score of 60 or higher, indicating they can carry out most daily activities.
- Must have good organ and bone marrow function.
- Must have mild or no nerve damage.
- If there are brain metastases, they must have been treated and stable for at least 3 months.
- Women and men must agree to use effective birth control during the study and for a period after treatment.
- Must be able to understand and agree to the study by signing a consent form.
Exclusion Criteria
- Cannot be taking other experimental cancer treatments.
- Cannot have a history of allergic reactions to similar drugs like docetaxel or paclitaxel.
- Cannot be taking certain medications that affect how the study drugs work.
- Cannot have uncontrolled illnesses such as ongoing infections, heart failure, or unstable heart conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have HIV and be on antiretroviral therapy due to potential drug interactions.
- Must be able to comply with the study's safety monitoring requirements.
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