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NCT00061984 · CITED IN SOURCE DOCUMENTS

Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-10-27

RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma * Locally advanced unresectable\* OR metastatic disease * High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: \*Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed * The following tumor types are eligible: * Malignant fibrous histiocytoma * Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma * Pleomorphic rhabdomyosarcoma * Synovial sarcoma * Myxofibrosarcoma, intermediate and high-grade * Fibrosarcoma * Leiomyosarcoma * Angiosarcoma * Malignant peripheral nerve sheath tumor * Epithelioid sarcoma * Alveolar rhabdomyosarcoma * Unclassifiable sarcoma, not otherwise specified * The following tumor types are not eligible: * Gastrointestinal stromal tumor * Mixed mesodermal tumor * Chondrosarcoma * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Ewing's sarcoma/primitive neuroectodermal tumor * Desmoplastic small round cell tumor * Embryonal rhabdomyosarcoma * Alveolar soft part sarcoma * Must have a measurable lesion with clinical evidence of progression within the past 6 weeks * Osseous lesions and pleural effusions are not considered measurable * No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 60 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.8 mg/dL * Albumin at least 2.5 g/dL Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance greater than 65 mL/min Cardiovascular * No history of cardiovascular disease Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other severe medical illness * No psychosis * No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for advanced or metastatic disease * Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the sole index lesion Surgery * Not specified
healthy Volunteers
false
maximum Age
60 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
Treatment arms and interventions
interventions
  1. name
    pegfilgrastim
    type
    BIOLOGICAL
  2. name
    doxorubicin hydrochloride
    type
    DRUG
  3. name
    ifosfamide
    type
    DRUG
  4. name
    multimodality therapy
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
455
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
secondary Outcomes
  1. measure
    Response as assessed by RECIST criteria
  2. measure
    Toxicity as assessed by CTC 2.0
  3. measure
    Treatment-related mortality
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.
detailed Description
OBJECTIVES: * Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy. * Compare the response in patients treated with these regimens. * Compare the treatment-related mortality of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3). * Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Source references
references
  1. citation
    Judson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litiere S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.
    pmid
    24618336
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        e (doxorubicin and ifosfamide vs. doxorubicin alone):</p> <div class="pdq-content-list"><ol id="_1580"><li>A randomized study (<a href="/clinicaltrials/NCT00061984">NCT00061984</a>) assessed whether dose intensification of doxorubicin and ifosfamide improved the survival of patients with advanced soft tissue sarcoma compa
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        n and ifosfamide vs. doxorubicin alone):</p> <div class="pdq-content-list"><ol id="_1580"><li>A randomized study (<a href="/clinicaltrials/NCT00061984">NCT00061984</a>) assessed whether dose intensification of doxorubicin and ifosfamide improved the survival of patients with advanced soft tissue sarcoma compared with doxo
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      source retrieved at
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      source title
      Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 21, 2025
        datetime
        2025-02-21T12:00:00Z
        display
        February 21, 2025

    Preserved source evidence · Not medical advice