CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma - Tabular View

Tracking Information

First Received Date ^ICMJE

June 6, 2001

Last Updated Date

July 23, 2008

Start Date ^ICMJE

October 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00017446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

Official Title ^ICMJE

Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas

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.

Detailed Description

OBJECTIVES:

Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma.
Determine the clinical toxic effects of this drug in these patients.

OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Sarcoma

Intervention ^ICMJE

Drug: CP4071

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00017446

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068689, CPMC-IRB-9825, NCI-G01-1952

Study Sponsor ^ICMJE

Herbert Irving Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Robert N. Taub, MD, PhD

Herbert Irving Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP