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| ID | Type | Description | Link |
|---|---|---|---|
| UNM-0903C | |||
| CDR0000355358 | Registry Identifier | PDQ (Physician Data Query) |
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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. 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
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors.
II. Determine the toxicity profile of this regimen in these patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (gemcitabine, irinotecan, alvocidib) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alvocidib | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity | 28 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Rabinowitz | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
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| gemcitabine hydrochloride | Drug | Given IV |
|
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| irinotecan hydrochloride | Drug | Given IV |
|
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| ID | Term |
|---|---|
| C077990 | alvocidib |
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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