Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

Completed · Phase 1

Conditions studied: Sarcoma

In brief

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.

Key facts

Study ID

NCT00004109

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

1998-03-01

Expected to finish

2011-04-01

Last updated by the study team

2012-08-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have cytologic or histologic proof of large (>5 mc), Grade III, resectable soft tissue sarcoma of the extremity or trunk (AJCC Stage IIIB). Patients with The American Joint Committee on Cancer (AJCC) Stage IIB tumors (Grade II) greater than 8 cms will also be eligible.
• Patients may have measurable or non-measurable disease (C/P pre-referral excision).
• Patients may have had prior doxorubicin (up to a total doxorubicin dose of 450 mg/m2).
• Patients may have a prior history of malignancy (at the discretion of the Principal Investigator).
• Patients must have Karnofsky Point Scale (P.S.)> of >70 or Xubrod P.S. of 0 or 1.
• 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%.
• Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.

You may not qualify if…

• Patients must not have had prior radiation therapy (XRT) in the area of the primary tumor, and the anticipated XRT field must not include the perineum, scrotum, or vaginal introitus.
• Patients with uncontrolled coexisting medical conditions are excluded.
• Patient must not be pregnant or brest feeding.

Where it is running

• University of Texas - MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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