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

Herbert Irving Comprehensive Cancer Center

Status and phase: Unknown; Phase 2

Conditions: Sarcoma

Treatments: Drug: CP4071

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00017446

NCI-G01-1952

CDR0000068689

CPMC-IRB-9825

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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