Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma
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ClinicalTrials.gov Identifier: NCT02945800 |
Recruitment Status :
Suspended
(Suspended until an amendment and updated ICF are available due to SAE occurance)
First Posted : October 26, 2016
Last Update Posted : March 2, 2023
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Condition or disease | Intervention/treatment | Phase |
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Osteosarcoma Ewing Sarcoma Rhabdomyosarcoma Soft Tissue Sarcoma | Drug: nab-Paclitaxel Drug: Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | N/A |
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 : | December 2023 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
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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.
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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 |
- 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.
- 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).
- 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.

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Ages Eligible for Study: | 3 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Connecticut | |
Connecticut Children's Medical Center | |
Hartford, Connecticut, United States, 06103 | |
United States, Delaware | |
A.I. duPont Hospital for Children, Delaware - Nemours | |
Wilmington, Delaware, United States, 19603 | |
United States, Florida | |
Shand's Hospital for Children at the University of Florida | |
Gainesville, Florida, United States, 32608 | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 | |
Holtz Children's Hospital at the University of Miami | |
Miami, Florida, United States, 33136 | |
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center | |
Tampa, Florida, United States, 33612 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40506 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
Carolinas Medical Center, Levine Cancer Institute | |
Charlotte, North Carolina, United States, 28303 | |
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 | |
United States, Tennessee | |
Vanderbilt - Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Javier E. Oesterheld, M.D. | Carolinas Medical Center, Levine Cancer Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | March 2, 2023 |
Last Verified: | February 2023 |
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 |
relapsed refractory soft tissue |
bones and joints non-rhabdomyosarcoma soft tissue sarcoma pediatric |
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 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 |