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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA062505 | U.S. NIH Grant/Contract | View source | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-PHI-28 | |||
| NCI-T99-0065 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy 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: Phase I trial to study the effectiveness of UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of cisplatin 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.
Patients are followed every 2-3 months for at least 1 year.
PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-hydroxystaurosporine | Drug | |||
| cisplatin | Drug |
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:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Gandara, MD | University of California, Davis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033-0804 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15958629 | Result | Lara PN Jr, Mack PC, Synold T, Frankel P, Longmate J, Gumerlock PH, Doroshow JH, Gandara DR. The cyclin-dependent kinase inhibitor UCN-01 plus cisplatin in advanced solid tumors: a California cancer consortium phase I pharmacokinetic and molecular correlative trial. Clin Cancer Res. 2005 Jun 15;11(12):4444-50. doi: 10.1158/1078-0432.CCR-04-2602. |
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| ID | Term |
|---|---|
| C054852 | 7-hydroxystaurosporine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| City of Hope Medical Group |
| Pasadena |
| California |
| 91105 |
| United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756-0002 | United States |