Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma

NCT ID: NCT02945800

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2025-02-17

Brief Summary

The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time during and after treatment that their disease does not get worse. Researchers also want to find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.

Conditions

Osteosarcoma; Ewing Sarcoma; Rhabdomyosarcoma; Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Therapy

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

Group Type: EXPERIMENTAL

nab-Paclitaxel

Intervention Type: DRUG

nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)

Gemcitabine

Intervention Type: DRUG

Gemcitabine: 1000 mg/m\^2 intravenously (IV)

Interventions

nab-Paclitaxel

nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)

Intervention Type: DRUG

Gemcitabine

Gemcitabine: 1000 mg/m\^2 intravenously (IV)

Intervention Type: DRUG

Other Intervention Names

Abraxane; Gemzar

Eligibility Criteria

Inclusion Criteria

• Participants must be age ≥ 3 and ≤ 30 years, and have had a histologic diagnosis of osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma either at diagnosis or relapse. Must have experienced relapse after front-line therapy, or have had documented disease progression during front-line therapy.
• Must have measurable disease that can be assessed using Response Evaluation in Solid Tumors (RECIST) 1.1, defined as the presence of at least one lesion on MRI or CT scan that can be accurately measured with the longest diameter of 10 mm in at least one dimension. For this phase II trial, patients with disease limited to bone or marrow metastases are NOT eligible, as disease at these sites cannot be assessed by RECIST 1.1 criteria.
• Must have relapsed or refractory cancers for which there is no known curative option.
• Prior Therapy: There is no limit to the number of prior therapies provided all eligibility criteria are met. However, participants must have recovered from the acute toxic effects of all prior treatment. (A) Must not have received prior therapy with either gemcitabine or nab-paclitaxel. (B) Myelosuppressive chemotherapy: Must not have received myelosuppressive chemotherapy within 3 weeks of protocol therapy on this study. (C) Hematopoietic growth factors: 7 days must have elapsed from the start of protocol therapy since the completion of therapy with filgrastim, and 14 days must have elapsed from the start of protocol therapy after receiving pegfilgrastim. (D) Biologic (anti-neoplastic agent): 7 day must have elapsed from the start of protocol therapy since the completion of therapy with a biologic agent. (E) Monoclonal antibodies: 3 half-lives must have elapsed from the start of protocol therapy since prior therapy that included a monoclonal antibody. (F) Radiotherapy: 2 weeks must have elapsed from the start of protocol therapy since local palliative radiotherapy (small port); 3 months must have elapsed if 50% radiation of pelvis; 6 weeks must have elapsed if other substantial bone marrow irradiation was given. (G) Stem Cell Transplant or Rescue: No evidence of active graft vs. host disease and 2 months must have elapsed from the start of protocol therapy since transplant.
• Karnofsky performance score must be ≥ 60
• Must have organ and marrow function
• Neuropathy: Must have ≤ grade 1 neuropathy at enrollment
• Central nervous system (CNS) Metastases: Potential participants with known CNS metastases are excluded unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months from the start of protocol therapy.
• Contraception: Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception 4 months after completion of gemcitabine and nab-paclitaxel administration.
• Consent: Participants must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria

• Potential participants who are receiving any other investigational agents
• Must not be receiving any additional medicines being given for the specific purpose of treating cancer
• A history of allergic reactions attributed to docetaxel or paclitaxel
• Concomitant Medications: The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. The following medicines should be avoided on this study because of their ability to inhibit or induce with CYP2C8 or CYP3A4: A) Inhibitors: ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir. B) Inducers: Rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine. C) Potential participants receiving any of the above medications are ineligible.
• Potential participants are ineligible if they have uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breastfeeding
• HIV Infection: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the study medications.
• Anyone who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Pediatric Cancer Foundation

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier E. Oesterheld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center, Levine Cancer Institute

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

A.I. duPont Hospital for Children, Delaware - Nemours

Wilmington, Delaware, United States

Shand's Hospital for Children at the University of Florida

Gainesville, Florida, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

Holtz Children's Hospital at the University of Miami

Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center

Tampa, Florida, United States

University of Kentucky

Lexington, Kentucky, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Carolinas Medical Center, Levine Cancer Institute

Charlotte, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

References

Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

Reference Type: DERIVED

PMID: 31401903 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://moffitt.org/clinical-trials-research/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

MCC-18613

Identifier Type: -

Identifier Source: org_study_id