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| Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036790 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.
| Condition | Intervention | Phase |
|
Breast Cancer Chronic Myeloproliferative Disorders Colorectal Cancer Head and Neck Cancer Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic/Myeloproliferative Diseases Prostate Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: doxorubicin hydrochloride Drug: motexafin gadolinium |
Phase I |
| Genetics Home Reference related topics: | Benign Tumors Bone Marrow Diseases Cancer Colorectal Cancer breast cancer |
| ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Motexafin gadolinium Motexafin Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies |
| Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.
Group A:
Group B:
Treatment in both groups continues for up to 6 courses in the absence of disease progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m^2.
Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A total of 3-48 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:
Histologically confirmed advanced malignancy that is considered incurable
Relapsed solid tumors include, but are not limited to the following sites:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex
Menopausal status
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, Pennsylvania | |||||
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |||||
| Pittsburgh, Pennsylvania, United States, 15232 | |||||
| United States, Wisconsin | |||||
| University of Wisconsin Comprehensive Cancer Center | |||||
| Madison, Wisconsin, United States, 53792 | |||||
| University of Wisconsin, Madison |
| National Cancer Institute (NCI) |
| Study Chair: | Markus Renschler, MD | Pharmacyclics |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069322, WCCC-CO-01910, PCI-PCYC-0207, NCI-G02-2061 |
| First Received: | May 13, 2002 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00036790 |
| Health Authority: | United States: Federal Government |
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