Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00061984|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : October 27, 2014
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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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: pegfilgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: multimodality therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||455 participants|
|Masking:||None (Open Label)|
|Official Title:||Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||July 2012|
- Overall survival
- Response as assessed by RECIST criteria
- Toxicity as assessed by CTC 2.0
- Treatment-related mortality
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
- Malignant mesothelioma
- 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
- 18 to 60
- WHO 0-1
- Not specified
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.8 mg/dL
- Albumin at least 2.5 g/dL
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance greater than 65 mL/min
- No history of cardiovascular disease
- 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:
- Not specified
- 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
- Not specified
- No prior radiotherapy to the sole index lesion
- Not specified
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): NCT00061984
|Study Chair:||Ian R. Judson, MA, MD, FRCP||Institute of Cancer Research, United Kingdom|
|Responsible Party:||European Organisation for Research and Treatment of Cancer - EORTC|
|Other Study ID Numbers:||
|First Posted:||June 6, 2003 Key Record Dates|
|Last Update Posted:||October 27, 2014|
|Last Verified:||October 2014|
adult epithelioid sarcoma
adult synovial sarcoma
stage III adult soft tissue sarcoma
adult malignant fibrous histiocytoma
stage II adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating