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| Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027898 |
Purpose
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin and etoposide in treating patients who have advanced solid tumors that have not responded to previous treatment.
| Condition | Intervention | Phase |
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: carboplatin Drug: etoposide |
Phase I |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Carboplatin Etoposide Etoposide phosphate Bortezomib |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy |
| Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of bortezomib, etoposide, and carboplatin.
Patients receive bortezomib IV on days 1 and 8, carboplatin IV over 30 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients with newly diagnosed, chemotherapy-naive extensive stage small cell lung cancer, and 6 patients with other tumor types, are treated at that dose.
PROJECTED ACCRUAL: A total of 12-27 patients will be accrued for this study within 6-14 months.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically stable CNS disease is allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Colorado | |||||
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |||||
| Aurora, Colorado, United States, 80045 | |||||
| University of Colorado at Denver and Health Sciences Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Lia Gore, MD, FAAP | University of Colorado at Denver and Health Sciences Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Gore L, Witta S, Pierson AS, et al.: A phase I study of PS-341 (P), carboplatin (C), and etoposide (E) in patients (pts) with advanced solid tumors. [Abstract] Clin Cancer Res 9: A-C74, 6221s, 2003.
  |
| Study ID Numbers: | CDR0000069091, UCHSC-COMIRB-01288, NCI-3171 |
| First Received: | December 7, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00027898 |
| Health Authority: | United States: Federal Government |
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