Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for Advanced Solid Tumors
Data Collection
Urogenital Diseases+25
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
The primary purpose of this study is to evaluate the safety, toxicities, and dosage for investigational drug Motexafin Gadolinium administered with docetaxel to patients with advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * ≥ 18 years old * Histologically or cytologically confirmed diagnosis of cancer (i.e., Unresectable locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) that had progressed during or after one or more chemotherapy regimens; Metastatic breast cancer; Hormone-refractory prostate cancer; Recurrent or refractory ovarian cancer; Sarcoma) * ECOG performance status score either 0 or 1 * Willing and able to provide written informed consent Exclusion Criteria: Laboratory Values of: * Absolute neutrophil count \< 2000/µL * Platelet count \< 100,00/µL * AST or ALT \> 1.5 x the upper limit of normal * Alkaline phosphatase \> 5 x the upper limit of normal * Bilirubin \> ULN * Creatinine \> 2.0 mg/dL and * Peripheral neuropathy NCI CTC Grade 3 or higher * Chemotherapy, radiation therapy, immunotherapy, or systemic biologic * anticancer therapy within 21 days before beginning study treatment * Known history of brain metastases or spinal cord compression * Uncontrolled hypertension * Myocardial infarction within 6 months before beginning study treatment * Unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled serious arrhythmias * Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80 * Known history of porphyria (testing not required at screening) * Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening) * Known history of HIV infection (testing not required at screening) * Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) * Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection * Physical or mental condition that makes patient unable to complete specified follow-up assessments
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location