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Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945800
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
National Pediatric Cancer Foundation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteosarcoma Ewing Sarcoma Rhabdomyosarcoma Soft Tissue Sarcoma Drug: nab-Paclitaxel Drug: Gemcitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Nab-Paclitaxel in Combination With Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults
Actual Study Start Date : October 25, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: nab-Paclitaxel
nab-Paclitaxel: 125 mg/m^2 intravenously (IV)
Other Name: Abraxane

Drug: Gemcitabine
Gemcitabine: 1000 mg/m^2 intravenously (IV)
Other Name: Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. Response Rate [ Time Frame: 13 months ]
    Treatment response will be assessed with the most relevant imaging studies (e.g., CT or MRI) after every two cycles. Standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to assess responses. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  2. Progression Free Survival (PFS) [ Time Frame: 13 months ]
    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm).


Secondary Outcome Measures :
  1. Occurrence of Study Treatment Related Adverse Events [ Time Frame: 13 months ]
    Adverse Events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0, deemed to be caused by study treatment.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be age ≥ 12 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945800


Contacts
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Contact: Tiffany Smith 813-745-6250 tiffany.smith@moffitt.org
Contact: Damon Reed, M.D. 813-745-2297 damon.reed@moffitt.org

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Dulce Lopez    323-361-3031    dulopez@chla.usc.edu   
Principal Investigator: Leo Mascarenhas, M.D.         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06103
Contact: Robin Ahrens    860-545-9614    Rahrens@connecticutchildrens.org   
Principal Investigator: Michael Isakoff, M.D.         
United States, Delaware
A.I. duPont Hospital for Children, Delaware - Nemours Recruiting
Wilmington, Delaware, United States, 19603
Contact: Pamela Cawood-Rizzo    302-651-5528    Pamela.Cawood@nemours.org   
Contact: Emi H. Caywood, M.D.    302-651-5500    Emi.Caywood@nemours.org   
Principal Investigator: Emi H. Caywood, M.D.         
United States, Florida
Shand's Hospital for Children at the University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Ashley Bayne    352-265-0111    abayne@ufl.edu   
Principal Investigator: Joanne Lagmay, M.D.         
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Kate Brannick    904-697-3206    kate.brannick@nemours.org   
Principal Investigator: Eric Sandler, M.D.         
Holtz Children's Hospital at the University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Michelle Liendo    305-585-5635    mliendo@med.miami.edu   
Principal Investigator: Julio Barredo, M.D.         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Ashley Repp    727-767-4784    ashley.repp@jhmi.edu   
Contact: Damon Reed    813-745-2297    damon.reed@moffitt.org   
Principal Investigator: Damon Reed, M.D.         
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center Recruiting
Tampa, Florida, United States, 33612
Contact: Tiffany Smith    813-269-0955 ext 480    TSmith@nationalpcf.org   
Principal Investigator: Damon Reed, M.D.         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Tammy Taylor    859-323-6975    tammy.taylor@uky.edu   
Principal Investigator: Lars Wagner, M.D.         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: David Loeb, M.D.    410-502-7247    loebda@jhmi.edu   
Principal Investigator: David Loeb, M.D.         
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Joyce Brown    718-741-1356    JOYCBROW@mentefiore.org   
Contact: Daniel A. Weiser    718-741-2347    dweiser@montefiore.org   
Principal Investigator: Daniel A. Weiser, M.D.         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Juanita Cuffee    919-843-7025    juanita_cuffee@med.unc.edu   
Principal Investigator: Patrick Thompson, M.D.         
Carolinas Medical Center, Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28303
Contact: Kimberly McKinney    704-381-9900    kimberly.mckinney@carolinashealthcare.org   
Principal Investigator: Javier E. Oesterheld, M.D.         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Amy Yekisa    614-722-6570    amy.yekisa@nationwidechildrens.org   
Principal Investigator: Bhuvana Setty, M.D.         
United States, Tennessee
Vanderbilt - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Scott C Borinstein, MD    615-936-1762    Scott.C.Borinstein@Vanderbilt.edu   
Principal Investigator: Scott C Borinstein, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Pediatric Cancer Foundation
Investigators
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Principal Investigator: Javier E. Oesterheld, M.D. Carolinas Medical Center, Levine Cancer Institute
More Information
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Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02945800    
Other Study ID Numbers: MCC-18613
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
relapsed
refractory
soft tissue
 bones and joints
non-rhabdomyosarcoma soft tissue sarcoma
pediatric
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs