Completed

NCT Number: NCT00036790

Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

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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Key information

Conditions

Breast Cancer Blast Crisis Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Myeloproliferative Disorders Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Epstein-Barr Virus Infections Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypopharyngeal Neoplasms Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Laryngeal Diseases Laryngeal Neoplasms Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lung Cancer Lung Diseases Lung Neoplasms Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Mouth Diseases Mouth Neoplasms Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Diseases Myeloproliferative Disorders Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Pharyngeal Diseases Pharyngeal Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Small Intestine Cancer Stomatognathic Diseases Thoracic Neoplasms Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin hydrochloride

Drug

motexafin gadolinium

Drug

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2005
First posted: Jan 27, 2003
Registry last updated: Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed