CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: CP4071 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas |
| Study Start Date: | October 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Study Chair: | Robert N. Taub, MD, PhD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00017446 History of Changes |
| Other Study ID Numbers: | CDR0000068689, CPMC-IRB-9825, NCI-G01-1952 |
| Study First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Digitoxin Cardiotonic Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013