CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Information provided by:
National Cancer Institute (NCI)
First received: June 6, 2001
Last updated: January 3, 2014
Last verified: September 2002
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.
||Primary Purpose: Treatment
||Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas
| Study Start Date:
- 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- Creatinine less than 1.5 times ULN
- Calcium less than ULN
- Potassium normal
- 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:
- Prior biologic response modifier therapy allowed
- No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
- No other concurrent chemotherapy
- No concurrent hormonal therapy for malignancy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- At least 4 weeks since prior surgery and recovered
- No other concurrent cardiac glycosides
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017446
|Herbert Irving Comprehensive Cancer Center
|New York, New York, United States, 10032 |
Herbert Irving Comprehensive Cancer Center
||Robert N. Taub, MD, PhD
||Herbert Irving Comprehensive Cancer Center
No publications provided
History of Changes
|Other Study ID Numbers:
||CDR0000068689, CPMC-IRB-9825, NCI-G01-1952
|Study First Received:
||June 6, 2001
||January 3, 2014
||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:
ClinicalTrials.gov processed this record on November 25, 2014
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs