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

Sarcoma Clinical Trial

Official title:

Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00017446
• Other study ID #: CDR0000068689
• Secondary ID: CPMC-IRB-9825NCI
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: January 3, 2014
• Start date: October 2000

Study information

• Verified date: September 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• CP4071

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,