Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma

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
Study Start Date :	October 21, 2016
Estimated Primary Completion Date :	March 2020
Estimated Study Completion Date :	March 2021

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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: Laurie Boan 860-545-9935 lboan@ccmckids.org
Principal Investigator: Michael Isakoff, M.S.
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: Matteo Trucco, 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 813-745-6250 tiffany.smith@moffitt.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
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.

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Pediatric Cancer Foundation

Investigators

Principal Investigator:	Javier E. Oesterheld, M.D.	Carolinas Medical Center, Levine Cancer Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Moffitt Cancer Center Clinical Trials website 

Responsible Party:	H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:	NCT02945800 History of Changes
Other Study ID Numbers:	MCC-18613
First Posted:	October 26, 2016
Last Update Posted:	January 12, 2018
Last Verified:	January 2018

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:

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; Paclitaxel; Gemcitabine; 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