Purpose

This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether these therapies can be safely combined and if they work better when given together in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.

Category

IRB Number
20150224HU
NCT Number
NCT02180867
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu



Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2/Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Alveolar Soft Part Sarcoma
    2. Angiomatoid Fibrous Histiocytoma
    3. Atypical Fibroxanthoma
    4. Clear Cell Sarcoma of Soft Tissue
    5. Epithelioid Malignant Peripheral Nerve Sheath Tumor
    6. Epithelioid Sarcoma
    7. Extraskeletal Myxoid Chondrosarcoma
    8. Extraskeletal Osteosarcoma
    9. Fibrohistiocytic Neoplasm
    10. Fibrosarcoma
    11. Inflammatory Myofibroblastic Tumor
    12. Intimal Sarcoma
    13. Leiomyosarcoma
    14. Liposarcoma
    15. Liver Embryonal Sarcoma
    16. Low Grade Fibromyxoid Sarcoma
    17. Low Grade Myofibroblastic Sarcoma
    18. Malignant Cutaneous Granular Cell Tumor
    19. Malignant Peripheral Nerve Sheath Tumor
    20. Malignant Triton Tumor
    21. Mesenchymal Chondrosarcoma
    22. Myxofibrosarcoma
    23. Myxoid Chondrosarcoma
    24. Myxoinflammatory Fibroblastic Sarcoma
    25. Nerve Sheath Neoplasm
    26. PEComa
    27. Pericytic Neoplasm
    28. Plexiform Fibrohistiocytic Tumor
    29. Sclerosing Epithelioid Fibrosarcoma
    30. Skin Glomus Tumor
    31. Stage IB Soft Tissue Sarcoma AJCC v7
    32. Stage IIB Soft Tissue Sarcoma AJCC v7
    33. Stage III Soft Tissue Sarcoma AJCC v7
    34. Stage IV Soft Tissue Sarcoma AJCC v7
    35. Synovial Sarcoma
    36. Undifferentiated High Grade Pleomorphic Sarcoma of Bone
    37. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Regimen A (pazopanib, chemoradiation)

      See Regimen A Detailed Description.
    38. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Drug: Pazopanib

        Given PO

        Other names:

        • GW786034

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Doxorubicin

        Given IV

        Other names:

        • Adriablastin
        • Hydroxydaunomycin
        • Hydroxyl Daunorubicin
        • Hydroxyldaunorubicin

      • Drug: Ifosfamide

        Given IV

        Other names:

        • Asta Z 4942
        • Asta Z-4942
        • Cyfos
        • Holoxan
        • Holoxane
        • Ifex
        • IFO
        • IFO-Cell
        • Ifolem
        • Ifomida
        • Ifomide
        • Ifosfamidum
        • Ifoxan
        • IFX
        • Iphosphamid

        • Drug: Pazopanib Hydrochloride

          Given PO

          Other names:

          • GW786034B
          • Votrient

        • Procedure: Therapeutic Conventional Surgery

          Undergo surgery

    39. Experimental

      Regimen C (pazopanib, radiation therapy)

      INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.
    40. Drug: Pazopanib

      Given PO

      Other names:

      • GW786034

    41. Radiation: Radiation Therapy

      Undergo radiation therapy

      Other names:

      • Cancer Radiotherapy
      • ENERGY_TYPE
      • Irradiate
      • Irradiated
      • Irradiation
      • Radiation
      • Radiation Therapy, NOS
      • Radiotherapeutics
      • Radiotherapy
      • RT
      • Therapy, Radia

    42. Drug: Pazopanib Hydrochloride

      Given PO

      Other names:

      • GW786034B
      • Votrient

    43. Procedure: Therapeutic Conventional Surgery

      Undergo surgery

    44. Experimental

      Regimen B (chemoradiation)

      See Regimen B Detailed Description.
    45. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Doxorubicin

        Given IV

        Other names:

        • Adriablastin
        • Hydroxydaunomycin
        • Hydroxyl Daunorubicin
        • Hydroxyldaunorubicin

      • Drug: Ifosfamide

        Given IV

        Other names:

        • Asta Z 4942
        • Asta Z-4942
        • Cyfos
        • Holoxan
        • Holoxane
        • Ifex
        • IFO
        • IFO-Cell
        • Ifolem
        • Ifomida
        • Ifomide
        • Ifosfamidum
        • Ifoxan
        • IFX
        • Iphosphamid

        • Procedure: Therapeutic Conventional Surgery

          Undergo surgery

    46. Experimental

      Regimen D (radiation therapy)

      INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.
    47. Radiation: Radiation Therapy

      Undergo radiation therapy

      Other names:

      • Cancer Radiotherapy
      • ENERGY_TYPE
      • Irradiate
      • Irradiated
      • Irradiation
      • Radiation
      • Radiation Therapy, NOS
      • Radiotherapeutics
      • Radiotherapy
      • RT
      • Therapy, Radia

    48. Procedure: Therapeutic Conventional Surgery

      Undergo surgery