Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
NCT ID: NCT00004109
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
1998-03-31
2011-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.
Detailed Description
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OUTLINE: This is a dose escalation study of doxorubicin. Patients receive doxorubicin intravenous (IV) bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity. Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment. Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation. Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks. Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. Patients are followed every 3 months for 3 years, every 4 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Doxorubicin + External-Beam RT
Doxorubicin Hydrochloride
Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
Radiation Therapy (RT)
External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
Interventions
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Doxorubicin Hydrochloride
Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
Radiation Therapy (RT)
External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients may have measurable or non-measurable disease (C/P pre-referral excision).
3. Patients may have had prior doxorubicin (up to a total doxorubicin dose of 450 mg/m2).
4. Patients may have a prior history of malignancy (at the discretion of the Principal Investigator).
5. Patients must have Karnofsky Point Scale (P.S.)\> of \>70 or Xubrod P.S. of 0 or 1.
6. Patients must have: Absolute neutrophil count (ANC) \> 1,500 cells/mm; platelet count \> 100,000 platelets/ml; serum creatinine \<1.8 mg/dl, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 3 times normal, total bilirubin \< 1.5mg/dl; for patients with cumulative Adriamycin 450 mg/M2, EF \>50%.
7. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.
Exclusion Criteria
2. Patients with uncontrolled coexisting medical conditions are excluded.
3. Patient must not be pregnant or brest feeding.
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Peter W. Pisters, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-ID-97335
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G99-1598
Identifier Type: -
Identifier Source: secondary_id
CDR0000067332
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID97-335
Identifier Type: -
Identifier Source: org_study_id