NCT00194766

Brief Summary

The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2000

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

September 14, 2005

Last Update Submit

November 13, 2007

Conditions

Breast CancerSoft Tissue Sarcoma

Keywords

Breast cancerSoft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    <= 78 months

Secondary Outcomes (3)

  • Time to disease progression

    <= 78 months

  • Survival

    <= 78 months

  • To determine the toxicity of the regimen.

    <= 78 months

Study Arms (1)

1

EXPERIMENTAL

Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.

Drug: Temozolomide

Interventions

TemozolomideDRUG

Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have either:
  • Stage IV, microscopically-confirmed carcinoma of the breast with:
  • Relapse or progression while receiving, or within 12 months of having received, an anthracycline-containing (doxorubicin or mitoxantrone) or taxane-containing (paclitaxel or docetaxel) regimen as either adjuvant treatment or therapy for advanced breast cancer, or
  • Treatment to a maximum dose of anthracycline (e.g., greater than 450 mg/m2 of doxorubicin), or
  • A dose-limiting toxicity from a taxane, or
  • An ECOG performance status of 2.
  • OR -
  • Unresectable or metastatic, microscopically-confirmed soft tissue sarcoma, that is not amenable to treatment with Adriamycin or Ifosfamide due to:
  • Poor cardiac reserve, or
  • Poor performance status (ECOG performance status = 2) or
  • Having failed treatment with Adriamycin or reached dose-limiting toxicity from chemotherapy.
  • Patients must have histologic slides and/or blocks must be available for review.
  • Patients must have measurable (bidimensionally) or evaluable disease.
  • Patients must be 18 years old or older.
  • Patients must have Karnofsky Performance Status greater than 70% (ECOG less than 2) at screen and on the first day of treatment.
  • +3 more criteria

You may not qualify if:

  • Granulocytes less than 1,500/mm3.
  • Platelet count less than 100,000/mm3.
  • Hemoglobin less than 10 gm/dl.
  • Creatinine greater than 2.0 mg/dl.
  • Total bilirubin greater than ULN (institutional upper limit of normal).
  • Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases (i.e. patients whose disease is beyond control).
  • Medically unstable (i.e. with uncontrolled disease); diagnosis of other systemic cancer.
  • Pregnancy or lactation; failure to employ adequate contraception.
  • Uncontrolled CNS disease.
  • Greater than 30% marrow previously irradiated.
  • Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsSarcoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • James Butrynski, M.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Study Start

July 1, 2000

Study Completion

December 1, 2006

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

US(1)