nab-Paclitaxel + Gemcitabine for Sarcoma

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen byJavier Oesterheld, M.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Javier Oesterheld, M.D.

Principal Investigator

Carolinas Medical Center, Levine Cancer Institute

Eligibility Criteria

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

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.

My organs and bone marrow are functioning well.

See 8 more

Exclusion Criteria

I am not taking medications that affect CYP2C8 or CYP3A4 enzymes.

I am not currently taking any cancer treatment medications.

I am allergic to docetaxel or paclitaxel.

See 5 more

Treatment Details

Interventions

Gemcitabine (Anti-metabolites)
nab-Paclitaxel (Anti-metabolites)

Trial OverviewResearchers are testing if nab-Paclitaxel combined with Gemcitabine can stop tumor growth in patients whose sarcomas returned or resisted earlier treatments. The goal is also to see how long patients stay stable without their disease worsening after this treatment combination.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment2 Interventions

Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.

Gemcitabine is already approved in Canada, Japan for the following indications: