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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098579 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Flavopiridol may also help doxorubicin work better by making tumor cells more sensitive to the drug. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol when given with doxorubicin in treating patients with metastatic or recurrent sarcoma that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor Sarcoma |
Drug: alvocidib Drug: doxorubicin hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Doxorubicin and Flavopiridol (NCI Supplied Agent, NSC 649890) in the Treatment of Metastatic Sarcoma |
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of flavopiridol.
Patients receive doxorubicin IV over 5-10 minutes and flavopiridol IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients reaching a cumulative doxorubicin dose of 600 mg/m^2 or experiencing cardiotoxicity may receive flavopiridol alone at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Ten additional patients receive treatment at the MTD.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1-2 years.
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*
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior cytotoxic chemotherapy regimens
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | David R. D'Adamo, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00098579 History of Changes |
| Other Study ID Numbers: | CDR0000398181, MSKCC-04075, NCI-6204 |
| Study First Received: | December 7, 2004 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
gastrointestinal stromal tumor recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
|
Gastrointestinal Stromal Tumors Sarcoma Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Doxorubicin |
Flavopiridol Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |