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Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert N. Taub, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068689

NCT ID:

NCT00017446

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma

Name

Location

Herbert Irving Comprehensive Cancer CenterNew York, New York  10032