|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of New Mexico National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079352 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 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 together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvocidib Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer |
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2004 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 8-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Study Chair: | Ian Rabinowitz, MD | University of New Mexico |
More Information
| Study ID Numbers: | CDR0000355358, UNM-0903C, NCI-6415 |
| Study First Received: | March 8, 2004 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00079352 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific |
|
Antimetabolites Flavopiridol Radiation-Sensitizing Agents Immunologic Factors Irinotecan Neoplasm Metastasis |
Gemcitabine Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Immunosuppressive Agents Antiviral Agents Camptothecin |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Irinotecan Enzyme Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Antiviral Agents Camptothecin Pharmacologic Actions Flavopiridol Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Gemcitabine Antineoplastic Agents, Phytogenic |