- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036790
Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Markus Renschler, MD, Pharmacyclics LLC.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- unspecified adult solid tumor, protocol specific
- recurrent metastatic squamous neck cancer with occult primary
- stage IV colon cancer
- recurrent colon cancer
- stage III colon cancer
- stage IIIC breast cancer
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- chronic myelomonocytic leukemia
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- limited stage small cell lung cancer
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV 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
- small intestine lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- accelerated phase chronic myelogenous leukemia
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- acute undifferentiated leukemia
- recurrent hypopharyngeal cancer
- stage III hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- recurrent laryngeal cancer
- stage III laryngeal cancer
- stage IV laryngeal cancer
- recurrent lip and oral cavity cancer
- stage III lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- recurrent nasopharyngeal cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- recurrent oropharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- recurrent paranasal sinus and nasal cavity cancer
- stage III paranasal sinus and nasal cavity cancer
- stage IV paranasal sinus and nasal cavity cancer
- untreated adult acute lymphoblastic leukemia
- meningeal chronic myelogenous leukemia
- T-cell large granular lymphocyte leukemia
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Hemorrhagic Disorders
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Intestinal Diseases
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Breast Neoplasms
- Head and Neck Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Plasmacytoma
- Intestinal Neoplasms
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Photosensitizing Agents
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
- Motexafin gadolinium
Other Study ID Numbers
- CDR0000069322
- P30CA014520 (U.S. NIH Grant/Contract)
- WCCC-CO-01910
- PCI-PCYC-0207
- NCI-G02-2061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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