Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00802880

Purpose

The purpose of this study is to determine the overall best tumor response rate to dacarbazine given until disease progression as assessed by RECIST criteria, CT and clinical exams in patients with metastatic sarcomas.

Condition	Intervention	Phase
Sarcoma	Drug: dacarbazine	Phase II

MedlinePlus related topics: Anatomy Cancer Soft Tissue Sarcoma

Drug Information available for: Dacarbazine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Determination of Tumor Response Rate by RECIST and FDG-PET Criteria to Dacarbazine in Metastatic Soft Tissue and Bone Sarcoma

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

The primary endpoint is to determine the overall best tumor anatomic response rate to dacarbazine given until disease progression as assessed by RECIST criteria using CT and clinical examination in patients with metastatic sarcoma. [ Time Frame: response to treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the overall risk of nausea/emesis (any grade) and neutropenia (grade 3 or 4) with up to six cycles of dacarbazine given with current antiemetic agents and with pegfilgrastim [ Time Frame: 30 days post last treatment ] [ Designated as safety issue: Yes ]
To compare the SUV at up to three target tumor sites as assessed by FDG-PET/CT performed at baseline and then after every three cycles of treatment with dacarbazine [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
To determine the overall tumor metabolic response as assessed by FDG-PET/CT performed at baseline and then after every three cycles of dacarbazine [ Time Frame: response ] [ Designated as safety issue: No ]
To correlate the tumor metabolic response to dacarbazine as assessed by PET/CT with the tumor anatomic response rate by RECIST criteria performed after every three cycles of dacarbazine [ Time Frame: response to treatment ] [ Designated as safety issue: No ]
To determine the overall disease control rate by RECIST criteria to dacarbazine given until disease progression [ Time Frame: response to treatment ] [ Designated as safety issue: No ]
To determine the time-to-progression and overall survival in patients treated with dacarbazine [ Time Frame: disease progression and overall survival ] [ Designated as safety issue: No ]
To correlate the overall best tumor metabolic response to dacarbazine as assessed by FDG-PET/CT and to correlate the overall best tumor anatomic response to dacarbazine by RECIST criteria to TTP and OS [ Time Frame: response to treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
dacarbazine: Experimental	Drug: dacarbazine dacarbazine 850mg/m2 IV over hour once every 3 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be enrolled in this study, patients must meet all of the following prerequisites:

Histologically proven diagnosis of soft tissue or bone sarcoma
Metastatic or locally recurrent and unresectable sarcoma which progressed after one or more prior chemotherapy regimens (excluding adjuvant chemotherapy).
At least one measurable tumor lesion (by CT scan)

At least one FDG avid (SUV >/= 3) tumor lesion (by PET/CT) which must have been performed at this institution. At least one of these target lesions must be ≥ 1.5 cm in smallest dimension as measured on the baseline CT

Age greater than 17 yrs
ECOG Performance Status of 0-2
Baseline ANC >/= 1000/uL, Hgb >/= 8 Gr/dL, platelets >/= 100,000/ dL.
Baseline serum creatinine </= 2.0 mg/dL
Baseline serum total bilirubin </= 2.0, AST or ALT < 3x ULN
No active infection
Signed Informed Consent

Exclusion Criteria:

Patients will be excluded from the clinical trial on the basis of any of the following:

Current pregnancy or breast feeding.
A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
Chemotherapy, radiation therapy, or investigational agents given with the last 21 days.
Investigational agents given with the last 30 days
Uncontrolled diabetes mellitus. (Subjects with a fasting blood glucose > 200 at time of PET scanning may need to reschedule to another day after consulting with appropriate physicians.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802880

Contacts

Contact: Douglas Adkins, M.D.

314-362-5740

dadkins@wustl.edu

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Douglas Adkins, M.D.

Washington Univerisity School of Medicine

More Information

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A, Natale RB, Cooper RM, Barlogie B, Trump DL, et al. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol. 1993 Jul;11(7):1276-85.

Gottlieb JA, Benjamin RS, Baker LH, O'Bryan RM, Sinkovics JG, Hoogstraten B, Quagliana JM, Rivkin SE, Bodey GP Sr, Rodriguez V, Blumenschein GR, Saiki JH, Coltman C Jr, Burgess MA, Sullivan P, Thigpen T, Bottomley R, Balcerzak S, Moon TE. Role of DTIC (NSC-45388) in the chemotherapy of sarcomas. Cancer Treat Rep. 1976 Feb;60(2):199-203.

Buesa JM, Mouridsen HT, van Oosterom AT, Verweij J, Wagener T, Steward W, Poveda A, Vestlev PM, Thomas D, Sylvester R. High-dose DTIC in advanced soft-tissue sarcomas in the adult. A phase II study of the E.O.R.T.C. Soft Tissue and Bone Sarcoma Group. Ann Oncol. 1991 Apr;2(4):307-9.

Borden EC, Amato DA, Rosenbaum C, Enterline HT, Shiraki MJ, Creech RH, Lerner HJ, Carbone PP. Randomized comparison of three adriamycin regimens for metastatic soft tissue sarcomas. J Clin Oncol. 1987 Jun;5(6):840-50.

Choi H, Charnsangavej C, Faria SC, Macapinlac HA, Burgess MA, Patel SR, Chen LL, Podoloff DA, Benjamin RS. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol. 2007 May 1;25(13):1753-9.

Responsible Party:	Washington University School of Medicine ( Douglas Adkins, M.D. )
Study ID Numbers:	08-X264
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802880
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Dacarbazine
Malignant mesenchymal tumor
Sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009