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| Descriptive Information Fields | |||||
| Brief Title † | Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer | ||||
| 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | 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 |
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| Intervention † | Drug: doxorubicin hydrochloride Drug: motexafin gadolinium |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | February 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00036790 | ||||
| Organization ID | CDR0000069322 | ||||
| Secondary IDs †† | WCCC-CO-01910, PCI-PCYC-0207, NCI-G02-2061 | ||||
| Study Sponsor † | University of Wisconsin, Madison | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2004 | ||||
| First Received Date † | May 13, 2002 | ||||
| Last Updated Date | July 23, 2008 | ||||