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

January 3, 2014 updated by: Herbert Irving Comprehensive Cancer Center

Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Robert N. Taub, MD, PhD, Herbert Irving Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

June 11, 2003

First Posted (Estimate)

June 12, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

September 1, 2002

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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