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nab-Paclitaxel + Gemcitabine for Sarcoma
Study Summary
This trial is testing a new cancer treatment to see if it can prevent tumors from growing or spreading in people with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or other soft tissue sarcomas. Researchers also want to see if the treatment is safe and tolerable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 & 3 trial • 191 Patients • NCT01881230Trial Design
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- My organs and bone marrow are functioning well.My cancer has returned or is not responding to treatment, and there is no cure known.I am not taking medications that affect CYP2C8 or CYP3A4 enzymes.I am not currently taking any cancer treatment medications.I am between 3 and 30 years old and have been diagnosed with a specific type of sarcoma.My cancer returned or got worse during my first treatment.I am allergic to docetaxel or paclitaxel.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not HIV-positive or not on antiretroviral therapy.My organs and bone marrow are functioning well.My nerve damage symptoms are mild or not present.I agree to use birth control during the study.My cancer can be measured and tracked using specific criteria.I can care for myself but may need occasional help.My cancer has returned or is not responding to treatment, and there is no cure.I have had multiple treatments as long as I meet all other study requirements.My brain metastases have been treated and stable for over 3 months.
- Group 1: Combination Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial offer enrollment opportunities at present?
"Affirmative. Clinicaltrials.gov data attests to the ongoing recruitment of participants for this trial, which was first introduced on October 25th 2016 and last updated November 17th 2022. 72 individuals need to be recruited from 16 sites in total."
Are there any other investigations that have explored the efficacy of nab-Paclitaxel?
"The first study of nab-Paclitaxel commenced over two decades ago, at the City of Hope Comprehensive Cancer Center. Since then, 1857 trials have concluded and 1113 are actively recruiting participants - many located in Bronx, New york."
What are the predominant indications for nab-Paclitaxel?
"Nab-Paclitaxel is commonly used to manage neoplasm metastasis and can also be employed in locally advanced non-small cell lung cancer, urinary bladder carcinoma, and metastatic bladder cancer."
What is the aggregate amount of volunteers participating in this clinical study?
"Yes, according to information on clinicaltrials.gov this medical study is still recruiting participants. It was initially published on October 25th 2016 and the most recent update occurred November 17th 2022; 72 people are necessary for 16 sites across the United States of America."
How many sites are presently managing this research project?
"The trial is in operation at various medical centres throughout the United States, including Montefiore Medical Center in Bronx, Connecticut Children's Medical Centre in Hartford, and Nemours Children's Clinic in Jacksonville. Additionally, there are 16 other sites hosting this study."
Has nab-Paclitaxel been cleared by the FDA?
"Nab-Paclitaxel has been given a safety rating of 2 due to the current absence of clinical data confirming its efficacy, but there is evidence that it is not excessively dangerous."
Do I fulfill the requirements to enter this experiment?
"This medical research is enrolling 72 individuals between the ages of three and thirty with a history of osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma. Applicants must have had their cancer relapse after primary treatment; however, they should not have received prior gemcitabine nor nab-paclitaxel myelosuppressive chemotherapy within 3 weeks of protocol therapy on this study. Furthermore, no biologic (anti-neoplastic agent), monoclonal antibodies, radiotherapy or stem cell transplant/rescue may be active at the time that protocol therapy commences—"
Is participation in this research endeavor limited to those under sixty years of age?
"The terms of eligibility for this trial state that the lowest age bracket to be admitted is 3 years old, while no one over 30 can participate."
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What portion of applicants met pre-screening criteria?
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