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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00004109

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Drug: Doxorubicin Hydrochloride Radiation: Radiation Therapy (RT)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Maximum Tolerated Dose (MTD) [ Time Frame: Continousouly during 5 weeks treatment ] [ Designated as safety issue: Yes ]
MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity

Enrollment:	30
Study Start Date:	March 1998
Study Completion Date:	April 2011
Primary Completion Date:	September 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Doxorubicin + External-Beam RT	Drug: Doxorubicin Hydrochloride Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks Other Name: doxorubicin Radiation: Radiation Therapy (RT) External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5). Other Names: RT Radialtherapy

Detailed Description:

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin when combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of the extremity or trunk. II. Assess the radiographic and pathologic response rates to this preoperative regimen in the subset of these patients with measurable disease.

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004109

Locations

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Peter W. Pisters, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Peter W. Pisters, M.D., UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00004109 History of Changes
Other Study ID Numbers:	ID97-335, P30CA016672, MDA-ID-97335, NCI-G99-1598, CDR0000067332
Study First Received:	December 10, 1999
Last Updated:	May 31, 2011
Health Authority:	United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:

stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
Doxorubicin
External-Beam RT
XRT
cancer
PREOPERATIVE CONCURRENT CHEMORADIATION

EXTREMITY SOFT TISSUE SARCOMAS
TRUNK SOFT TISSUE SARCOMAS
Concurrent Chemoradiation
Surgical Resection
Localized Extremity Soft Tissue Sarcomas
Body Wall Soft Tissue Sarcomas

Additional relevant MeSH terms:

Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012