NCT00017446

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
Last Updated

January 6, 2014

Status Verified

September 1, 2002

First QC Date

June 6, 2001

Last Update Submit

January 3, 2014

Conditions

Sarcoma

Keywords

stage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage IV adult soft tissue sarcoma

Interventions

CP4071DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed soft tissue sarcoma * Metastatic or locally advanced * Failed at least 1 prior therapy * Measurable disease outside prior irradiation field * No CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: * Creatinine less than 1.5 times ULN * Calcium less than ULN * Potassium normal Other: * No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic response modifier therapy allowed Chemotherapy: * No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy for malignancy Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * At least 4 weeks since prior surgery and recovered Other: * No other concurrent cardiac glycosides

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Digitoxin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Robert N. Taub, MD, PhD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

June 12, 2003

Study Start

October 1, 2000

Last Updated

January 6, 2014

Record last verified: 2002-09

Locations

US(1)