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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072436 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and flavopiridol, use 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 gemcitabine and flavopiridol in treating patients with solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvocidib Drug: gemcitabine hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial Of Gemcitabine Followed By A Short Infusion Of Flavopiridol In Patients With Solid Tumors |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2003 |
| Estimated Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
Some patients receive an initial dose of flavopiridol IV over 1-7 hours on day 1 (course 0). Beginning 1 week later and for all subsequent courses, all patients receive gemcitabine IV over 60-150 minutes on days 1 and 15 and flavopiridol IV over 1-7 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and 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. Once the MTD is determined, up to 10 additional patients receive treatment at that dose.
Patients are followed at 30 days after study completion.
PROJECTED ACCRUAL: A total of 40-80 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:
Must meet criteria for 1 of the following:
Measurable disease
Nonmeasurable disease, including any of the following:
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following within the past 6 months:
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior chemotherapy regimens
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Geoffrey Shapiro, MD, PhD 617-632-4942 geoffrey_shapiro@dfci.harvard.edu | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Gary K. Schwartz, MD 212-639-8324 | |
| Study Chair: | Geoffrey Shapiro, MD, PhD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000339727, DFCI-03110, NCI-6051 |
| Study First Received: | November 4, 2003 |
| Last Updated: | April 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072436 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Flavopiridol Neoplasms Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Gemcitabine |