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| Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00112684 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as 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 stimulate the immune system in different ways and stop tumor cells from growing. It may also stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with locally advanced or metastatic solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvocidib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Flavopiridol in Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, dose-escalation study.
Patients receive flavopiridol IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease after 4 courses of therapy discontinue study treatment. Patients who achieve complete remission (CR) receive 1 additional course of therapy beyond documentation of CR.
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. A total of 10 patients are treated at the MTD.
After completion of study treatment, patients are followed within 4 weeks.
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 solid tumor
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Study Chair: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Study ID Numbers: | CDR0000429582, OSU-04111, OSU-2005C0009, NCI-7204 |
| Study First Received: | June 2, 2005 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00112684 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific |
|
Flavopiridol Protein Kinase Inhibitors |
|
Flavopiridol Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Enzyme Inhibitors Growth Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |