Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Wisconsin, Madison
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036790
First received: May 13, 2002
Last updated: November 16, 2008
Last verified: September 2004
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Breast Cancer
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Colorectal Cancer
Fungal Infections
Head and Neck Cancer
Hodgkin Disease
Intestinal Cancer
Leukemia
Lung Cancer
Lymphoma
Multiple Myeloma
Oral Cancer
Prostate Cancer
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | February 2002 |
OBJECTIVES:
- Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Evaluate the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.
Group A:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and 10 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment repeats every 21 days.
Group B:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and motexafin gadolinium as in group A.
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 |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed advanced malignancy that is considered incurable
- Recurrent or metastatic disease
Relapsed solid tumors include, but are not limited to the following sites:
- Lung
- Breast
- Colon
- Prostate
- Head and neck
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex
- Not specified
Menopausal status
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- LVEF greater than 45% at rest
- No prior myocardial infarction
- No congestive heart failure
- No clinically significant ventricular arrhythmias
Other:
- No history of HIV infection
- No history of porphyria
- No glucose-6-phosphate dehydrogenase deficiency
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 28 days since prior chemotherapy
- No prior lifetime cumulative doxorubicin exposure of more than 300 mg/m^2
- No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 28 days since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- No concurrent surgery
Other:
- At least 14 days since prior multidrug resistance-modulating drugs (e.g., PSC833 or cyclosporine)
- No other concurrent antineoplastic or investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036790
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 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Study Chair: | Markus Renschler, MD | Pharmacyclics |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00036790 History of Changes |
| Other Study ID Numbers: | CDR0000069322, WCCC-CO-01910, PCI-PCYC-0207, NCI-G02-2061 |
| Study First Received: | May 13, 2002 |
| Last Updated: | November 16, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia |
relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia refractory hairy cell leukemia chronic myelomonocytic leukemia T-cell large granular lymphocyte leukemia acute undifferentiated leukemia stage III grade 1 follicular lymphoma |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Colorectal Neoplasms Head and Neck Neoplasms Leukemia Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myeloproliferative Disorders Prostatic Neoplasms Lymphoma, Large-Cell, Immunoblastic Duodenal Neoplasms |
Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Myelodysplastic-Myeloproliferative Diseases Neoplasms by Site Breast Diseases Skin Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 22, 2013