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| Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006464 |
Purpose
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.
| Condition | Intervention | Phase |
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: 7-hydroxystaurosporine Drug: cisplatin |
Phase I |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Cisplatin UCN 01 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors |
| Study Start Date: | March 2001 |
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.
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, California | |||||
| City of Hope Medical Group | |||||
| Pasadena, California, United States, 91105 | |||||
| University of California Davis Cancer Center | |||||
| Sacramento, California, United States, 95817 | |||||
| USC/Norris Comprehensive Cancer Center and Hospital | |||||
| Los Angeles, California, United States, 90033-0804 | |||||
| United States, New Hampshire | |||||
| Norris Cotton Cancer Center | |||||
| Lebanon, New Hampshire, United States, 03756-0002 | |||||
| Beckman Research Institute |
| National Cancer Institute (NCI) |
| Study Chair: | David R. Gandara, MD | University of California, Davis |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068274, CHNMC-PHI-28, NCI-T99-0065 |
| First Received: | November 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006464 |
| Health Authority: | United States: Federal Government |
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